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05.012.001.0004-4 国际定性产品手册.semnat
05.012.001.0004-4 国际定性产品手册.semnat
Guangzhou Wondfo Biotech Co., Ltd., located in Guangzhou, China, is a globally recognized fast growing POCT
company devoted to the R&D, manufacture and sales of rapid diagnostic reagents and related equipment in IVD (in
vitro diagnostic) field.
Founded in 1992, the company is continually expanding its scale. Apart from the Guangzhou headquarters, Wondfo
also owns two overseas R&D center, one branch in Chicago and other twelve overseas offices. Wondfo went public in
June, 2015 (Stock Code: 300482), and has more than 1,500 employees with 30% of them obtained postgraduate
degrees.
As one of the earliest high-tech biological companies focusing on rapid diagnostics for toxicology, infectious diseases,
fertility, cardiovascular disease, tumor, respiratory disease, renal injury and diabetes, Wondfo has won good reputation
around the world. In addition, Wondfo has got CE certificates, FDA certificates, FSC certificates, ISO 9001:2015 and
ISO 13485:2016 quality system certification.
We are dedicated to making the world a better place by providing people with high quality products and services.
ISO 13485 ISO9001 CE FDA
Infectious
Disease
Dr
Ab ugs
Fe st
Te
us of
e rti
lit
y
POCT
Family cuClaardiova
ST st
Di r s-
Te
se
D
as
e
Tumor
Marker
CONTENTS
01 Infectious Disease Series
Hepatitis
HIV
Malaria
H. Pylori
Flu
Dengue
Others
03 Fertility Series
HCG
LH
FSH
Sperm Concentration Test
HBsA
One
Ste
p HBs g
Ag
Wh
ole
Bloo
CON d Tes
1. 25 TENTS: t
2. Alco test cass 25
3. Lanc hol pad ettes tests
4. Clea ets s (opt (with
(opt iona desi
5. Leaf ring iona l) ccan
buff
let with l) t pou
er in ch and
instr a drop drop
uctio per per)
ns for bott
use. le.
Leading
POCT Man
ufacture
r
er
factur
Manu
PO CT
China
4
, P.R.
hou
ngz
01 Wondfo Biotech
Parameters
Flu
Hepatitis
Buffer
2 drops (50 μL)
HIV-Syphilis
T1 T2 C T1 T2 C T1 T2 C
10 ul 9 3 T1 T2 C
6
A B A B 15 min Negative
T1 T2 C T1 T2 C T1 T2 C T1 T2 C
Sample well Buffer well
Wondfo Biotech 02
Fertility Tests
W1-S hCG Pregnancy Test Strip 2.5/3.0/3.5/4 mm Urine 25/20/10 mIU/mL 0537
W1-C hCG Pregnancy Test Cassette 4.0 mm Urine 25/20/10 mIU/mL 0537
W1-C I hCG Pregnancy Test Cassette 3.5 mm Urine 25/20/10 mIU/mL 0537
W1-M hCG Pregnancy Test Midstream 6.0 mm Urine 25/20/10 mIU/mL 0537
W1-M II hCG Pregnancy Test Midstream 5.0 mm Urine 25/20/10 mIU/mL 0537
W1-M III hCG Pregnancy Test Midstream 6.0 mm Urine 25/20/10 mIU/mL 0537
W1-M4 hCG Pregnancy Test Midstream 3.5 mm Urine 25/20/10 mIU/mL 0537
W1-M6 hCG Pregnancy Test Midstream 6.0 mm Urine 25/20/10 mIU/mL 0537
W121-S Sperm Concentration Test Strip 2.5/3.0/3.5mm Semen 15x10^6 /mL 0123
W121-C Sperm Concentration Test Cassette 4.0 mm Semen 15x10^6 /mL 0123
C
T
DM-102 (Disposable)
03 Wondfo Biotech
Parameters
Strip
12
Please make the
LH
specimen level
under the Max line. 9 3
3 min
Urine
9 3
Positive Negative Invalid
Marker Line
6
5 min
Serum
Cassette
12
4 drops
(100 μL)
9 3
6
C T
ID
3 min
Urine
4 drops 12
(100 μL) Positive Negative Invalid
9 3
C T 6
ID
Serum 5 min
Midstream
12
9 3
Or
6
Positive Negative Invalid
5 min
Or
Pregnant Not Pregnant
Wait Error
Wondfo Biotech 04
DOA Urine Tests
THC/MET/MDMA/OPI/PCP/TCA/TRA/BUP
PPX/EDDP/K2 etc.
Various formats: Strip, Cassette, Multi - Test Panel, Multi - Test Cup
05 Wondfo Biotech
One Step DOA Test
Wondfo Biotech 06
Qualification
One Step DOA Test
One step
C T
ID
12
9 3
07 Wondfo Biotech
DOA Oral Fluid Tests
W6506 Oral Fluid Multi-Drug 6 Test 6 Items Cassette Oral Fluid Variable
(AMP/BZO/COC/THC/MET/MOP)
W602 Multi-Drug Oral Fluid 2 Test Cup 2 Items T-Cube Oral Fluid Variable
W603 Multi-Drug Oral Fluid 3 Test Cup 3 Items T-Cube Oral Fluid Variable
W604 Multi-Drug Oral Fluid 4 Test Cup 4 Items T-Cube Oral Fluid Variable
W605 Multi-Drug Oral Fluid 5 Test Cup 5 Items T-Cube Oral Fluid Variable
W606 Multi-Drug Oral Fluid 6 Test Cup 6 Items T-Cube Oral Fluid Variable
W607 Multi-Drug Oral Fluid 7 Test Cup 7 Items T-Cube Oral Fluid Variable
W608 Multi-Drug Oral Fluid 8 Test Cup 8 Items T-Cube Oral Fluid Variable
W609 Multi-Drug Oral Fluid 9 Test Cup 9 Items T-Cube Oral Fluid Variable
W610 Multi-Drug Oral Fluid 10 Test Cup 10 Items T-Cube Oral Fluid Variable
Wondfo Biotech 08
Tumor Marker Tests
W30-S FOB (Fecal Occult Blood) Test Strip 2.5/3.0/4.0 mm Feces 200 ng/mL
FOB (Fecal Occult Blood) is the trace amount of blood in feces which Lead
ing
POCT
Manu
factur
er
can not be seen with eyes. It could be the early clinical symptom of the FOB
One
Ste
p FO
B Wh
ole
Blo
od Tes
CONT t
1. 25 ENTS:
2. Alco test cas 25
3. Lan hol sett test
es (wi s
4. Cle cets pads (op th des
r
ture
ufac
Man
CT
in g PO
Lead
FOR IN
VIT RO DI
AGNO STIC US
E ONLY
ina
. Ch
u, P.R
4
zho
ang
, Gu
663
510
. trict,
., Ltd g Dis
h Co gan 063
tec Luo 296
Bio e City, -20-32
ndfo enc :0086
u Wo ad, Sci Fax
gzhohan Ro 083 .cn
GuanLizhis -32296 fo.com
8
No. 086-20 w.wond
09 Wondfo Biotech
Parameters
Sampling stick
3-4 drops
C T
ID
12
9 3
10 min
FOB
FOB
FOB
FOB
Wondfo Biotech 10
STD (Sexually Transmitted Disease) Tests
HIV: 2 NCU/mL
W107 Syphilis - HIV Test Cassette Cassette Whole Blood
TP: 2 NCU/mL
Lead
ing
POCT
Manu
factur
er
Syphil
One
Ste
p Sy
is - HIV
ph ilis
- HI
V Wh
CONT ole
Blo
1. 25 ENTS od Te
st
2. Alc test cas : 25
3. Lan ohol pad settes tests
4. Cle cets s (with
(optio (optional desicc
5. Lea aring ant
flet buffe nal) ) pouch
with r in and
instru a dropp dropp
ctio er bo er)
ns for ttle.
use.
Leading
POCT Ma
nufactur
er
rer
actu
anuf
TM
POC
ing
Lead
FOR IN
VITR O DIAG
NO STIC US
E ONLY
ina
. Ch
u, P.R
4
ho
angz
, Gu
0663
ct, 51
Ltd. Distri
Co., ang 6063
h og 29
otec y, Lu -32
o Bi e Cit 86-20
ondf ienc 00
u W ad, Sc Fax:
gzhohan Ro 6083 cn
GuanLizhis -3229 fo.com.
8
No. 0086-20 w.wond
Tel: ite:ww
Webs
11 Wondfo Biotech
Parameters
4 drops
8 drops 8 drops Ch lamydia
12
9 3
10-15 min
Chlamydia Chlamydia
Positive(+) Positive(+)
Wondfo Biotech 12
Other Rapid Tests
Lea
ding
POCT
Manuf
acture
r
Alco
One
h
Ste
p Alco ol
hol
Wh
ole
Blo
CON od Tes
1. 25 TENTS: t
2. Alco test cass 25
3. Lan hol ette tests
pad s
4. Clea cets (opt s (opt (with desi
5. Lea ring iona iona ccan
buff l) l) t pou
flet er in ch and
with a drop
inst drop
ruct per per)
ions bott
for use le.
.
Leading
er
factur
Manu
POCT
ing
Lead
FOR IN
VITRO
DIAGN
na
. Chi
4
, P.R
hou
ngz
, Gua
663
510
. trict,
, Ltd g Dis
h Co. gan 063
tec , Luo -32296
Parameters
12
Please make the
LH
specimen level
under the Max line. 9 3
Compare the reactive pad with the provided colored chart above
13 Wondfo Biotech
OUR VISION
Provide professional products and services of rapid diagnosis and chronic disease management; pursue
Pursue
better and convenient user experience; promote
Promote high-standard
high-standard life
life and
and health
health quality;
quality; fulfill
Fulfillshared
shareddreams
dream
of our staff, customers and partners.
London
Frankfurt Chicago Branch
Bucharest
Istanbul
Istanbul
Cairo
Guangzhou
Abuja San Diego Lab
Delhi
Nairobi
Jakarta Manila
Cape Town
Belo Horizonte
1,500+ Employees
1,100+
200+ R&D Staffs
2 Overseas Lab
1
1 Branch
10+
12 Overseas
OverseasOffices
Offices
Rev.: DX-CG-XX-02
2019/04/12