Product catalogue

About Fujirebio
Fujirebio is a global leader in the field of high quality in vitro diagnostics (IVD) testing.

Fujirebio (the name is pronounced Fuji-Ray-Bee-o and symbolizes restoration of health) has more than 50 years’
experience in the discovery, development, manufacturing and worldwide commercialization of robust IVD products.

Historically based in Japan with the country’s deeply rooted culture of excellence Fujirebio has over the years been
shaped by the successful integration of pioneering and experienced international IVD players such as the diagnostics
business of Centocor in 1998, CanAg Diagnostics in 2006 and Innogenetics in 2010. Today, Fujirebio’s global pres-
ence includes offices in the United States, Europe, Latin America and Asia as well as a vast international distribution
network.

Fujirebio IVD product lines span from specialized manual testing to fully automated routine clinical laboratory testing
solutions and include both novel and routine biomarkers. They cover a variety of disease states such as infectious,
oncology, genetic testing, thyroid, fertility, tissue typing, neurodegeneration and bone metabolism.

As early pioneers back in 1992 Fujirebio launched one the World’s first fully automated chemiluminescent enzyme
immunoassay systems, the early LUMIPULSE® in Japan. Today Fujirebio is the 2nd largest immunoassay instrument
supplier on the Japanese market. The latest generation of the LUMIPULSE series of chemiluminescent assays and
analyzers was brought to new markets in Asia and Europe in 2011 and, in 2016, to the United States.

Fujirebio also has a strong and long lasting tradition for developing high quality routine and truly novel biomarkers
in collaboration with the clinical community worldwide.
Established in 1950 Fujirebio is today a fully owned subsidiary of Miraca Holdings (listed in the Tokyo Stock Exchange
- MRCHF) and employ more than 1.200 people in Asia, Europe and America, including subsidiaries.

Please visit www.fujirebio-europe.com to locate your nearest distributor.

Corporate office: Fujirebio Europe NV

Technologiepark 6 - B-9052 Gent - Belgium
T +32 (0)9 329 13 29 - F +32 (0)9 329 17 75
p. 2 www.fujirebio-europe.com
Lumipulse diagnostics product portfolio
Fujirebio has been committed to solid and succesful automated immunoassay testing solutions since 1992
offering state-of-the-art chemiluminescent products focused on the following key areas:

• Tumor markers
- Complete routine oncology panel with gold • Neurodegeneration
standard antibodies: AFP, CEA, CA125, CA19-9, - β-Amyloid 1-42
CA15-3, PSA and fPSA, β2m(serum/urine) - β-Amyloid 1-40*
- Specialized state of the art products: PIVKA-II, CYFRA, - Total Tau
HE4, Pepsinogen I & II, ProGRP and Mesothelin - pTau 181*

• Thyroid • Infectious diseases

-TSH, FT3, FT4, T3, T4, TPOAb and TgAb - HBsAg-Quant
- HBcIgM
- HBeAg
• Fertility - HBeAb
- LH, FSH, Prolactin, β-HCG, Testosterone, Progesterone, - HBcrAg**
Estradiol and Anti-Mullerian Hormone* - Syphilis
- HTLV I/II
• Diabetes
- Insulin and C-peptide, HMW Adiponectin • Cardiac
- BNP, Myoglobin, CK-MB and Hs Troponin I
• Anemia
- Ferritin • Instrumentation
Fujirebio offers fully automated solutions with the
• Interstitial pneumonia LUMIPULSE® G1200 and G600II providing maximum safety
- KL-6 features for its CLEIA technology using unitary cartridges
with a constant throughput of respectively 120 tests and 60
• Bone tests per hour.
- 25-OH Vitamin D
- whole PTH (3rd generation PTH)

• Inflammation
- IgE
- Procalcitonin
* In development
- Interleukin-6 (IL-6)** ** For Research Use Only

p. 3
Tumor markers

Alpha-fetoprotein (AFP) description art. no.

• Lumipulse® G AFP-N Immunoreaction Cartridges 3 × 14 Tests 292846

F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
alpha-fetoprotein (AFP) in serum or plasma.

• Lumipulse® G AFP-N Calibrators 1 x 3 x 1.5 ml 230602

Beta 2-microglobulin (β2m)

• Lumipulse® G ß2M-N Immunoreaction Cartridges 3 × 14 Tests 292914
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
ß2-microglobulin (ß2m) in serum, plasma and urine.

• Lumipulse® G ß2M-N Calibrators (serum/plasma) 1 x 3 x 1.5 ml 230749

• Lumipulse® G ß2M-N Calibrators (urine) 1 x 3 x 1.5 ml 230374


CA125II
• Lumipulse® G CA125II Immunoreaction Cartridges 3 × 14 Tests 292631
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
CA125 in serum or plasma.

• Lumipulse® G CA125II Calibrators 1 x 2 x 1.5 ml 230688

CA15-3
• Lumipulse® G CA15-3 Immunoreaction Cartridges 3 × 14 Tests 292648
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
CA15-3 in serum or plasma.

• Lumipulse® G CA15-3 Calibrators 1 x 2 x 1.5 ml 230640

CA19-9
• Lumipulse® G CA19-9-N Immunoreaction Cartridges 3 × 14 Tests 292655
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
CA19-9 in serum or plasma.

• Lumipulse® G CA19-9-N Calibrators 1 x 2 x 1.5 ml 230664

Carcinoembryonic antigen (CEA)

• Lumipulse® G CEA-N Immunoreaction Cartridges 3 × 14 Tests 292662
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
carcinoembryonic antigen (CEA) in serum or plasma.

• Lumipulse® G CEA-N Calibrators 1 x 2 x 1.5 ml 230626

p. 4
Cytokeratin subunit 19 fragment (CYFRA) description ART. NO.

• Lumipulse® G CYFRA Immunoreaction Cartridges 3 × 14 Tests 292945

F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
cytokeratin subunit 19 fragment (CYFRA) in serum.

• Lumipulse® G CYFRA Calibrators set 4 x 4 x 0.5 ml 230701

Prostate specific antigen (PSA)

• Lumipulse® G PSA-N Immunoreaction Cartridges 3 × 14 Tests 292853
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
prostate specific antigen (PSA) in serum or plasma.

• Lumipulse® G PSA-N Calibrators 1 x 3 x 1.5 ml 231456

• Lumipulse® G Free PSA Immunoreaction Cartridges 3 × 14 Tests 297766

For in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
free prostate specific antigen (free PSA) in human serum or plasma. The Lumipulse® G Free PSA
assay is intended to be used in conjunction with the Lumipulse® G PSA-N assay to determine
the % free PSA value in men aged 50 years or older whose total PSA values are between 4
and 10 ng/mL and whose DRE is not suspicious for cancer. The % free PSA value can be used
as an aid in distinguishing prostate cancer from benign disease.

• Lumipulse® G Free PSA Calibrators 1 × 3 × 1.5 ml 234006

Protein induced vitamin K absence or antagonist-II (PIVKA-II)

• Lumipulse® G PIVKA-II Immunoreaction Cartridges 3 × 14 Tests 233184
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
protein induced by vitamin K absence or antagonists-II (PIVKA-II) in serum.

• Lumipulse® G PIVKA-II Calibrators set 2 x 3 x 0.5 ml 233191

Pro-gastrin-releasing peptide (ProGRP)

• Lumipulse® G ProGRP Immunoreaction Cartridges 3 × 14 Tests 297858
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
Pro-gastrin-releasing peptide [ProGRP (31-98)] in serum and plasma. The ProGRP assay is intended
to be used as an aid in differential diagnosis and for monitoring of patients with small cell lung cancer.

• Lumipulse® G ProGRP Calibrators set 2 x 3 x 0.5 ml 233160

HE4
• Lumipulse® G HE4 Immunoreaction Cartridges 3 × 14 Tests 234068
 For in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
HE4 in serum and plasma.

• Lumipulse® G HE4 Calibrators 1 x 2 x 1.5 ml 234075

p. 5
 Pepsinogen I and II description art. no.

• Lumipulse® G Pepsinogen I and II Immunoreaction Cartridges 3 × 14 Tests 292983(I)

F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement 3 x 14 Tests 292990(II)
of Pepsinogen I and II in serum or plasma.

• Lumipulse® G Pepsinogen I and II Calibrators 1 x 2 x 1.5ml 233450(I)

1 x 2 x 1.5ml 233474(II)

Mesothelin (SMRP)
• Lumipulse® G Mesothelin Immunoreaction Cartridges 3 x 14 Tests 294192
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
Mesothelin (SMRP) in serum or plasma.

• Lumipulse® G Mesothelin Calibrators 1 x 3 x 1.5ml 233436

Thyroid

Anti-thyroglobulin antibodies (TgAb) description art. no.

• Lumipulse® G TgAb Immunoreaction Cartridges set*** 3 × 14 Tests 230558

F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of 1 x 2 x 2 ml
anti-thyroglobulin antibodies in serum or plasma.

Anti-thyroid peroxidase antibodies (TPOAb)

• Lumipulse® G TPOAb Immunoreaction Cartridges set*** 3 × 14 Tests 230572
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of 1 x 3 x 2ml
anti-thyroid peroxidase antibodies in serum or plasma.

Free triiodothyronine (FT3)

• Lumipulse® G FT3-III Immunoreaction Cartridges 3 × 14 Tests 297582
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
free triiodothyronine (FT3) in serum or plasma.

• Lumipulse® G FT3-III Calibrators 1 x 3 x 1.5 ml 233825

*** includes calibrators

p. 6
Free thyroxine (FT4) description art. no.

• Lumipulse® G FT4-N Immunoreaction Cartridges 3 × 14 Tests 294680

For in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
free thyroxine (FT4) in serum or plasma.

• Lumipulse® G FT4-N Calibrators 1 x 3 x 1.5 ml 230503

Thyroid-stimulating hormone (TSH)

• Lumipulse® G TSH-III Immunoreaction Cartridges 3 × 14 Tests 294604
For in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
thyroid-stimulating hormone (TSH) in serum or plasma.

• Lumipulse® G TSH-III Calibrators 1 x 3 x 1.5 ml 231135

Thyroxine (T4)
• Lumipulse® G T4 Immunoreaction Cartridges 3 × 14 Tests 294451
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
thyroxine (T4) in serum or plasma.

• Lumipulse® G T4 Calibrators 1 x3 1.5 ml 230541

Triiodothyronine (T3)
• Lumipulse® G T3 Immunoreaction Cartridges 3 × 14 Tests 294413
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
triiodothyronine (T3) in serum or plasma.

• Lumipulse® G T3 Calibrators 1 x 3 x 1.5 ml 230527

p. 7
Neurodegeneration

β-Amyloid 1-42 description art. no.

• Lumipulse® G β-Amyloid 1-42 Immunoreaction Cartridges 3 x 14 Tests 230336

F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
β-Amyloid 1-42 in human cerebrospinal fluid.

• Lumipulse® G β-Amyloid 1-42 Calibrators set 2 x 3 x 1 ml 230343

Total Tau
• Lumipulse® G Total Tau Immunoreaction Cartridges 3 x 14 Tests 230312
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
total Tau in human cerebrospinal fluid.

• Lumipulse® G Total Tau Calibrators set 2 x 3 x 1 ml 230329

β-Amyloid 1-40*
• Lumipulse® G β-Amyloid 1-40 Immunoreaction Cartridges 3 × 14 Tests 231524
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
β-Amyloid 1-40 in human cerebrospinal fluid.

• Lumipulse® G β-Amyloid 1-40 Calibrators set 2 x 3ml 231531

pTau 181*
• Lumipulse® G pTau 181 Immunoreaction Cartridges
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of 3 x 14 Tests 230350
pTau in human cerebrospinal fluid.

• Lumipulse® G pTau 181 Calibrators 2 x 3ml 230367

Cardiac

BNP
• Lumipulse® G BNP Immunoreaction Cartridges 3 x 14 Tests 296899
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
human B-type natriuretic peptide (BNP) in human EDTA plasma.

• Lumipulse® G BNP Calibrators set 2 x 3 x 0.5 ml 230435

* in development

p. 8

 description art. no.
CK-MB
• Lumipulse® G CK-MB Immunoreaction Cartridges 3 x 14 Tests 298169
For in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
the MB isoenzyme of creatine kinase (CK-MB) in human serum or plasma.

• Lumipulse® G CK-MB Calibrators set 2 x 2 x 0.5 ml 230299



Myoglobin
• Lumipulse® G Myoglobin Immunoreaction Cartridges 3 × 14 Tests 298145
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
myoglobin in human serum or plasma.

• Lumipulse® G Myoglobin Calibrators 1 x 2 x 1.5 ml 230305

hs Troponin I
• Lumipulse® G hs Troponin I Immunoreaction Cartridges 3 x 14 Tests 298121
For in vitro diagnostic use with the LUMIPULSE® G System for the quantitative and high sensitive
measurement of cardiac troponin I in serum or plasma.

• Lumipulse® G hs Troponin I Calibrators 1 x 3 x 2.5 ml 230282

Fertility


Beta Human Chorionic Gonadotropin (βHCG)
• Lumipulse® G ßHCG Immunoreaction Cartridges 3 × 14 Tests 295151
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
total beta human chorionic gonadotropin (βHCG) in serum or plasma.

• Lumipulse® G ßHCG Calibrators 1 x 2 x 1.5 ml 231111

Follicle-stimulating hormone (FSH)

• Lumipulse® G FSH-N Immunoreaction Cartridges 3 x 14 Tests 230923
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
follicle-stimulating hormone (FSH) in serum or plasma.

• Lumipulse® G FSH-N Calibrators 1 x 2 x 1,5 ml 230930

p. 9
Luteinizing hormone (LH) description art. no.

• Lumipulse® G LH Immunoreaction Cartridges 3 × 14 Tests 292822

F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
luteinizing hormone (LH) in serum or plasma.
1 x 2 x 1.5 ml 230916
• Lumipulse® G LH Calibrators

Prolactin (PRL)
• Lumipulse® G Prolactin Immunoreaction Cartridges 3 × 14 Tests 292839
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
prolactin in serum or plasma.

• Lumipulse® G Prolactin Calibrators 1 x 2 x 1.5 ml 230954

Testosterone
• Lumipulse® G Testosterone Immunoreaction Cartridges 3 × 14 Tests 292952
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
testosterone in serum or plasma.

• Lumipulse® G Testosterone Calibrators 1 x 6 x 1.5 ml 230862

Estradiol (E2)
• Lumipulse® G E2-III Immunoreaction Cartridges 3 × 14 Tests 296011
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
estradiol (E2) in serum or plasma.

• Lumipulse® G E2-III Calibrators 1 x 3 x 1.5 ml 233849

Progesterone (PRG)
• Lumipulse® G Progesterone-N Immunoreaction Cartridges 3 x 14 Tests 295564
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
progesterone (PRG) in serum or plasma.

• Lumipulse® G Progesterone-N Calibrators 1 x 3 x 1.5 ml 230893

Anti-Mullerian Hormone* (AMH)

• Lumipulse® G AMH Immunoreaction Cartridges 3 x 14 Tests 298381
 For in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
Anti-Mullerian Hormone (AMH) in serum or plasma.
1 x 3 x 1.5 ml 235423
• Lumipulse® G AMH Calibrators set

* in development

p. 10
Diabetes & Inflammation

C-peptide description art. no.

• Lumipulse® G C-Peptide Immunoreaction Cartidges 3 × 14 Tests 292679

F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
C-peptide in serum or plasma.

• Lumipulse® G C-Peptide Calibrators 1 x 2 x 1.5 ml 230770

Insulin
• Lumipulse® G Insulin-N Immunoreaction Cartridges 3 × 14 Tests 292938
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
insulin in serum or plasma.

• Lumipulse® G Insulin-N Calibrators 1 x 2 x 1.5 ml 230800

HMW Adiponectin
• Lumipulse® G HMW Adiponectin Immunoreaction Cartridges 3 x 14 Tests 234778
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
High Molecular Weight (HMW) Adiponectin in serum or plasma.

• Lumipulse® G HMW Adiponectin Calibrators set 2 x 3 x 0.5 ml 234785

Immunoglobulin E (IgE)
• Lumipulse® G IgE Immunoreaction Cartridges 3 × 14 Tests 292815
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
immunoglobulin E (IgE) in serum or plasma.

• Lumipulse® G IgE Calibrators 1 x 2 x 1.5 ml 230824

Procalcitonin (PCT)
• Lumipulse® G B. R. A. H. M. S PCT Immunoreaction Cartridges 3 x 14 Tests 297902
 For in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
Procalcitonin in serum or plasma.

• Lumipulse® G B. R. A. H. M. S PCT Calibrators set 2 x 2 x 0.5 ml 234150

Interleukin (IL-6)**
• IL-6 LPG Immunoreaction Cartridges RUO 3 x x14 Tests 293423
 For in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
IL-6 in serum or plasma.

• IL-6 LPG Calibrators RUO 1 x 4 x 1.5 ml 295212

** For Research Use Only

p. 11
Infectious diseases

Treponema Pallidum (TP) description art. no.

• Lumipulse® G TP-N Immunoreaction Cartridges set*** 3 × 14 Tests 231142

F or in vitro diagnostic use with the LUMIPULSE® G System for the qualitative detection of 1 x 2 x 2 ml
Treponema pallidum (TP) antibodies in serum or plasma.

Hepatitis B virus
• Lumipulse® G HBsAg-Quant Immunoreaction Cartridges 3 x 14 Tests 296851
For in vitro diagnostic use with the LUMIPULSE® G System for the qualitative and quantitative
detection of hepatitis B surface antigen (HBsAg) in human serum or plasma.

• Lumipulse® G HBsAg-Quant Calibrators 1 × 6 x 2 ml 233139

• Lumipulse® G HBsAg-Quant Confirmation 1 x 2 x 1.2 ml 233146

• Lumipulse® G HBclgM Immunoreaction Cartridges set*** 3 x 14 Tests 231494

F or in vitro diagnostic use with the LUMIPULSE® G System for the qualitative detection of IgM 1 x 2 x 2 ml
antibody to hepatitis B core antigen (anti-HBcIgM) in human serum or plasma.

• Lumipulse® G HBeAb-N Immunoreaction Cartridges set*** 3 × 14 Tests 233108

 For in vitro diagnostic use with the LUMIPULSE® G System for the qualitative detection of 2 × 2 x 2 ml
antibody to hepatitis B ‘e’ antigen (anti-HBe) in human serum or plasma.

• Lumipulse® G HBcrAg Immunoreaction Cartridges set*** RUO 3 × 14 Tests 294109

For research use, with the LUMIPULSE® G System for the quantitative detection of 1 x 2 x 1.5 ml
hepatitis B virus core-related antigen in human serum or plasma.

• Lumipulse® G HBeAg Immunoreaction Cartridges set*** 3 x 14 Tests 231517

For in vitro diagnostic use with the LUMIPULSE® G System for the qualitative detection of 2 x 2 x 1.5 ml
hepatitis B ‘e’ antigen (anti-HBe) in human serum or plasma.

HTLV I/II
• Lumipulse® G HTLV-I/II Immunoreaction Cartridges set*** 3 x 14 Tests 234617
For in vitro diagnostic use with the LUMIPULSE® G System for the qualitative detection of 1 x 2 x 1.5ml
antibody to human T-cell lymphotropic virus type I (HTLV- I) and type II (HTLV- II) in human
serum or plasma.

*** Includes calibrators

p. 12
Bone

25-OH Vitamin D description art. no.

• Lumipulse® G 25-OH Vitamin D Immunoreaction Cartridges 3 × 14 Tests 234013

The Lumipulse G 25-OH Vitamin D Assay uses LUMIPULSE® G System with chemiluminescent
enzyme immunoassay (CLEIA) technology for the quantitative determination of 25-hydroxyvitamin
D (25-OH-D) in human serum or plasma to be used in the assessment of vitamin D sufficiency.

• Lumipulse® G 25-OH Vitamin D Calibrators 1 x 6 x 1.5 ml 234020

Whole-Parathyroid Hormone (whole PTH)
• Lumipulse® G whole PTH Immunoreaction Cartridges 3 × 14 Tests 297094
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
whole (1-84) PTH in human serum or plasma.

• Lumipulse® G whole PTH Calibrators 1 x 3 ml 230206

1 x 1.5 ml

Anemia

Ferritin
• Lumipulse® G Ferritin-N Immunoreaction Cartridges 3 × 14 Tests 292969
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
ferritin in serum or plasma.

• Lumipulse® G Ferritin-N Calibrators 1 x 2 x 1.5 ml 230848

Interstitial pneumonia

Krebs von den Lungen (KL-6)
• Lumipulse® G KL-6 Immunoreaction Cartridges 3 × 14 Tests 233207
F or in vitro diagnostic use with the LUMIPULSE® G System for the quantitative measurement of
sialylated carbohydrate antigen, KL-6 in serum or plasma.

• Lumipulse® G KL-6 Calibrators 1 x 3 x 1.5 ml 233214

p. 13
Consumables

description art. no.

• Disposable waste container for LUMIPULSE® SYSTEM (G600II) 1 x 20 units 306932

• Printer paper for LUMIPULSE® SYSTEM (G600II) 1 x 5 pcs 306918

• Disposable bags for LUMIPULSE® SYSTEM (G1200) 50 306697

• Hitachi sample cup 250 units 80351

• Lumipulse® G Dilution Cartridges 3 x 14 tests 230466

• Sampling tips for LUMIPULSE® SYSTEM (G1200) 12 x 96 304945

• Sampling tips for LUMIPULSE® SYSTEM (G600II) 10 x 96 302392

• Soda Lime for LUMIPULSE® SYSTEM 6 x 2 tubes 234440

• CSF tube adapters 1 x 5 units 232040

• Substrate cap seal 1 x 2 units 306642

Common reagents

• Lumipulse® G Wash Solution 1 x 1000 ml 231173

This product is a common reagent used for washing in the LUMIPULSE® G System.

• Lumipulse® G Substrate Solution (G1200) 6 x 100 ml 231197

 This product is a common reagent used for enzyme reactions in the LUMIPULSE® G System.

• Lumipulse® G Substrate Solution (G600II) 6 x 50 ml 231166

 This product is a common reagent used for enzyme reactions in the LUMIPULSE® G System.

• Lumipulse® G Specimen Diluent 1 (G1200) 4 x 300 ml 231203

This product is a common reagent used for diluting specimens in the LUMIPULSE® G System.

• Lumipulse® G Specimen Diluent 1 (G600II) 4 x 80 ml 231180

This product is a common reagent used for diluting specimens in the LUMIPULSE® G System.

• Lumipulse® G Specimen Diluent 2 1 x 20 ml 230985

 This product is a special reagent used for diluting specimens in the Lumipulse® G E2-III.

• Lumipulse® G Specimen Diluent 3 1 x 20 ml 230879

 This product is a special reagent used for diluting specimens in the Lumipulse® G Testosterone.

• Lumipulse® G Specimen Diluent 4 1 x 20 ml 231555

 This product is a special reagent used for diluting specimens in the Lumipulse® G T3 and T4.

• Lumipulse® G Specimen Diluent 5 1 x 20 ml 233177

 This product is a special reagent used for diluting specimens in the Lumipulse® G ProGRP.

• Lumipulse® G Specimen Diluent 6 1 x 20 ml 234693

 This product is a special reagent used for diluting specimens in the Lumipulse® G Progesterone-N.

p. 14
Instrumentation

• LUMIPULSE® G1200 art. no.

Simplify your work using LUMIPULSE G1200 technology and solutions. The fully automated CLEIA 232002
analyzer processes mono-test cartridges at a rate of 120 tests/hour, a consistent throughput
regardless of assay mix .

p. 15
 art. no.
• LUMIPULSE® G600II

 Simplify your work using LUMIPULSE G600II as a personalized solution. The benchtop CLEIA analyzer 703380
processes mono-test cartridges at a rate of 60 tests/hour, a consistent throughput regardless of assay mix .

p. 16
Controls

art. no.
• Lumipulse® PIVKA-II and KL-6 Controls
 For in vitro diagnostic use: This control is intended for use as an assayed control serum to monitor the precision
 233801
of laboratory testing procedures for the analysis of PIVKA-II and KL-6 using LUMIPULSE® G Systems.
Level 1: 3 x 1ml Level 2: 3 x 1ml

• Tumor Marker Control

Fujirebio Tumor Marker Control is intended for use as an assayed control serum to monitor the
precision of laboratory testing procedures for the analysis of Tumor Markers. This control contains the analytes for HE4, 108-20
CA15-3, CA19-9, CA 125, AFP, CEA, PSA, fPSA, Ferritin.
Level 1: 3 x 3ml Level 2: 3 x 3ml

• Vitamin D Control
Fujirebio Vitamin D Control is intended for use as an assayed control serum to monitor the precision 2130152
of laboratory testing procedures for the analysis of Vitamin D. This control contains both 25(OH) Vitamin D2 and
25(OH) Vitamin D3; and when combined represent clinically relevant levels of Total Vitamin D.
Level 1: 2 x 2ml Level 2: 2 x 2ml Level 3: 2 x 2 ml

• Lumipulse® PTH Controls

For in vitro diagnostic use: These controls are intended for use as an assayed quality control to monitor the precision 230213
of laboratory testing procedures for the analysis of whole (1-84) PTH on the LUMIPULSE® G Systems.
Level 1: 2 x 3ml Level 2: 2 x 3ml

• ProGRP Control
For in vitro diagnostic use: This control is intended for use as an assayed control serum to monitor the precision 230-20
of laboratory testing procedures for the analysis of ProGRP using LUMIPULSE® G Systems.
Level 1: 3 x 1ml Level 2: 3 x 1ml

• Lumipulse® β-Amyloid 1-42 Controls

For in vitro diagnostic use: These controls are intended for use as an assayed quality control to monitor the precision 230244
of laboratory testing procedures for the analysis of β-Amyloid 1-42 using LUMIPULSE® G Systems.
Level 1: 2 x 1ml Level 2: 2 x 1 ml Level 3: 2 x 1 ml

• Lumipulse® Total Tau Controls

For in vitro diagnostic use: These controls are intended for use as an assayed quality control to monitor the precision 230237
of laboratory testing procedures for the analysis of total Tau using LUMIPULSE® G Systems.
Level 1: 2 x 1 ml Level 2: 2 x 1 ml Level 3: 2 x 1 ml

• Lumipulse® β-Amyloid Controls*

For in vitro diagnostic use: These controls are intended for use as an assayed quality control to monitor the precision
of laboratory testing procedures for the analysis of β-Amyloid 1-40 and 1-42 using LUMIPULSE® G Systems.

• Lumipulse® pTau 181 Controls*
For in vitro diagnostic use: These controls are intended for use as an assayed quality control to monitor the precision
of laboratory testing procedures for the analysis of pTau using LUMIPULSE® G Systems.

* In development

Assigned values for controls are available. For more info on these and on external quality controls, contact your local representative.

p. 17
Controls

art. no.

• Lumipulse® B. R. A. H. M. S PCT Controls 234167
 For in vitro diagnostic use: These controls are intended for use as an assayed control material to monitor the

precision of laboratory testing procedures for the analysis of procalcitonin on the LUMIPULSE® G Systems.
Level 1: 6 x 1 ml Level 2: 6 x 1 ml

• Lumipulse® HBcrAg Controls 298015

RUO
F or research use only: These controls are intended for use as an assayed control material to monitor the
precision of laboratory testing procedures for the analysis of HBcrAg using LUMIPULSE® G Systems.
Level 1: 2 x 1.5 ml Level 2: 2 x 1.5 ml

• Lumipulse® Mesothelin control 360-020

For in vitro diagnostic use: This control is intended for use as an assayed quality control serum to monitor the
precision of laboratory testing procedures for the analysis of Mesothelin using LUMIPULSE® G Systems.
Level 1: 1 x 1 ml Level 2: 1 x 1 ml

• Lung marker control 240-20

For in vitro diagnostic use: These controls are intended for use as an assayed quality control serum to monitor
the precision of laboratory testing procedures for the analysis of CYFRA, ProGRP using LUMIPULSE® G Systems.
Level 1: 2 x 3 ml Level 2: 2 x 3 ml

• Lumipulse® BNP Controls 230442
For in vitro diagnostic use: These controls are intended for use as an assayed quality control to monitor the
precision of laboratory testing procedures for the analysis of human B-type natriuretic peptide (BNP) on the
LUMIPULSE® G Systems.
Level 1: 6 x 1 ml Level 2: 6 x 1 ml

• Lumipulse® Pepsinogen I/II Controls 234587

For in vitro diagnostic use: These controls are intended for use as an assayed control to monitor the precision of
laboratory testing procedures for the analysis of Pepsinogen I and Pepsinogen II on the LUMIPULSE® G Systems.
Level 1: 3 x 3 ml Level 2: 3 x 3 ml

• Diamex QConnect Controls*

For in vitro diagnostic use: This multi-marker control is intended for use as an assayed control to monitor
the performance of laboratory testing procedures for the analysis of HBsAg, Anti-HTLV IgG, Anti-Treponema
pallidum IgG, Anti-HIV 1 IgG, Anti-HBc and Anti-HCV IgG analytes in human serum and plasma.

• QConnect Blue*
 For in vitro diagnostic use: This multi-marker control is intended for use as an assayed control to monitor SR01011
the
performance of laboratory testing procedures for the analysis of Anti-HIV 1, IgG Anti-HBc, Anti-HTLV Ig, SR01012
Anti-HCV IgG HBsAg, Anti-Treponema pallidum IgG analytes in human serum and plasma.
4 x positive x 5 ml
2 x positive x 5 ml, 2 x negative x 5ml

• Seronorm Controls L1/2 206805

For in vitro diagnostic use: This multi-marker control is intended for use as an assayed quality control serum to
monitor the precision of laboratory measurement procedures.
Level 1: 12 x 3 ml Level 2: 12 x 3 ml

* Coming soon

p. 18
 2016
The LUMIPULSE®
G1200, a mid-sized,
cartridge-based
instrument for fully
2015 automated CLEIA
The LUMIPULSE® testing, is launched
L2400, a high in the USA.
volume instrument
using bottle-type
reagents is launched 2014
in Japan. The LUMIPULSE®
G600II, a compact
cartridge-based
CLEIA benchtop
2011 analyzer, is launched
The LUMIPULSE® in Europe and Asia.
G1200, a mid-sized,
cartridge-based
instrument for fully
automated CLEIA
testing, is launched
2010

When you
in Europe and Asia. Acquisition of
Innogenetics NV
(Belgium), world

pave the way

leader in specialty
2007 molecular and im-
munoassay testing.
The Japanese Red

you have to
Cross choose LUMI-
PULSE® as their
blood screening
system. 2006
Acquisition of CanAg
Diagnostics AB
(Sweden), leader in carve every step
with care
oncology biomarker
2005 development.
Fujirebio Inc. be-
comes a fully owned
subsidiary of
Miraca Holdings Inc.
2001
Fujirebio is accredit-
ed with
ISO 13485, ISO 9001,
EN46001 and
1998 ISO 14001 certifica-
Acquisition of Cen- tions.
tocor Diagnostics
(USA), pioneer in
oncology testing and
developer of CA125II,
CA19-9 and CA15-3.
1995
The INNOTEST®
hTAU Ag kit is the
world’s first com-
mercialised
1992 biomarker for early
detection of Alzhei-
Fujirebio launches
mer’s Disease.
the original
LUMIPULSE® 1200
instrument in Japan.
Launch of the first 1987
specialised infectious Fujirebio Inc. is
disease tests on the listed on the TSE
INNO-LiPA®, INNO-LIA® (Tokyo Stock Exchange)
and INNOTEST® plat- – 1st section.
forms.

1985
Launch of Immuno-
clone CA19-9, the first
1978
carbohydrate oncolo- Launch of the
gy assay. syphilis SERO-
DIA®-TP•PA test kit,
destined to become
1966 the gold standard.

Launch of HA Ag
(TPHA), the first
hemagglutination
test for syphilis.
1950
Fujirebio (formerly
Fujizoki Pharmaceutical,
Co., Inc.) is founded in
Tokyo, Japan.

p. 19
 © Fujirebio Europe, March 2018, FRE-033, r2
Fujirebio Europe Corporate Office: Sales Assistance:
Fujirebio Europe NV Tel.: +32-9-329-1417
Technologiepark 6 Fax: +32-9-329-1775
B-9052 Gent e-mail: info@fujirebio.com
BELGIUM
BTW BE 0427.550.660 - Companies Register Gent
Tel.: +32-9-329-1329 Order Handling:
Fax: +32-9-329-1911 Tel.: +32-9-329-1516 - +32-9-329-1527
e-mail: info@fujirebio-europe.com Fax: +32-9-245-7613
website: www.fujirebio.com e-mail: orderhandling@fujirebio.com

Customer Support:
Tel.: +32-9-329-1611
Fax: +32-9-329-1911
e-mail: customer.support@fujirebio.com

Lumipulse, SERODIA and INNOTEST are registered trademarks of Fujirebio.

CE marked products listed in this catalog are not available as an IVD in the US, Canada and some other countries.
Please contact your commercial representative for further details on its local availability.

Technologiepark 6- B-9052 Gent - Belgium

T +32 (0)9 329 13 29 - F +32 (0)9 329 17 75
www.fujirebio-europe.com