4/28/23, 2:18 PM TNC Everlight Philippines, Inc.

Mail - Request of Non-Coverage Certificate

Lea Mendoza <lea.mendoza.ra@tnceverlight.com>

Request of Non-Coverage Certificate

CDRRHR LRD <cdrrhr.lrd@fda.gov.ph> Wed, Apr 26, 2023 at 6:23 PM
To: Lea Mendoza <lea.mendoza.ra@tnceverlight.com>, "FDAC . Letters" <fdac.letters@fda.gov.ph>

Dear Ms. Mendoza:

The list of registrable IVD product is reflected in the a ached issuance. IVD products aside from the listed is
considered non registrable IVD products. A valid LTO of the importer is enough to present upon entry of the
product.

This serves as our official response during this pandemic which you can show to BOC or any
other government transaction.
Very truly yours,

LICENSING AND REGISTRATION DIVISION

Center for Device Regulation, Radiation Health and Research
Food and Drug Administration
/02

From: Lea Mendoza <lea.mendoza.ra@tnceverlight.com>

Sent: Wednesday, April 26, 2023 10:47 AM
To: CDRRHR LRD <cdrrhr.lrd@fda.gov.ph>; FDAC . Letters <fdac.letters@fda.gov.ph>
Subject: Request of Non-Coverage Certificate

[Quoted text hidden]

https://mail.google.com/mail/u/0/?ik=b5202bd437&view=pt&search=all&permmsgid=msg-f:1764233959939061515&simpl=msg-f:17642339599390615… 1/2
26 April 2023

Dr. Samuel A. Zacate

Director General

Food and Drug Administration

Attention: Ma.Cecilia C. Matienzo

Director IV - Center for Device Regulation, Radiation Health and
Research

Subject: Request of Non-Coverage Certificate for the following non-registrable IVD

Reagents/Analyzer

Greetings!

We would like to request a Non-Coverage Certificate from your good office that the
following IVD reagents/analyzer do not require any certificate or registration from Food and
Drug Administration. Thus, the company’s LTO and FDA CIRCULAR 2020-001 and AO
018-002 can suffice for importation/customs clearance and public bidding purposes.

Attached here are the supporting documents for your reference:

1. LTO - CDRRHR-NCR-MDI-512288
2. Addition of Source - SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,
LTD.
3. List of Products

Thank you and we are hoping to merit your kind approval on this matter.

Sincerely,

Lea Mae R. Mendoza, RPh

Regulatory Affairs Pharmacist
 Republic of the Philippines
Department of Health
Food and Drug Administration
Civic Drive, Filinvest Corporate City
Alabang, Muntinlupa City

LICENSE TO OPERATE
as

Medical Device
Distributor-Importer
is hereby granted to

TNC EVERLIGHT PHILIPPINES, INC.

Unit 5B Country Space 1 Bldg., Sen. Gil Puyat Avenue, Salcedo Village,
Makati, Metro Manila, National Capital Region, 1200, Makati, None

Owner: TNC Everlight Philippines, Inc.

License Number: CDRRHR-NCR-MDI-512288
Application Type: Renewal
Date of Issuance: 23 January 2023
Validity of License: 03 March 2025

This LTO shall be renewed within 90 days before its expiration, upon compliance with relevant
laws, rules and regulations and the payment of fees. This LTO may be suspended, cancelled or
revoked by this Office for cause if found violating RA 9711 and related issuances.

Furthermore, with this LTO, the FDA allows the establishment to apply for a market authorization
[i.e. registration (CPR) or notification] for health products prior to manufacture, importation, sale or
offer for sale, distribution, transfer and advertisement as the case may be.

DR. SAMUEL A. ZACATE

Director General

This electronic-LTO (eLTO) is computer generated and does not require signature
5/20/2021 FIS - FDA Home

Republic of the Philippines

Deparment of Health
Food and Drug Administration

ACKNOWLEDGEMENT RECEIPT

The Food and Drug Administration (FDA) hereby acknowledges the receipt of your document
with the following details and duly recorded in the FDA Inventory System (FIS):

Document Tracking No:

20210520091750

Communication Type: LTO - Add Source

From: TNC EVERLIGHT PHILIPPINES INC

Routed to: Center for Device Regulation, Radiation Healt

ADD SOURCE LTO No:3000007381938

Document Title: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.-CHINA

Contact Information: lea.mendoza.ra@tnceverlight.com

Received By: MAASFlores

Date and Time Received: 20 May 2021 09:17:50 AM

The determination of the completeness of the documentary requirements submitted, if any, is subject to the evaluation of the
technical person in charge.

You may follow-up the status of your document through the DocTrack Status at the FDA website, http://www.fda.gov.ph/doctrack-
status-know-the-status-of-your-application, using the document tracking number and the contact information stated above.

The receipt is systems generated and does not require signature.

https://doctrack.fda.gov.ph/screens/fis_dtn_details.php?rsn=20210520091750 1/1
Updated as of Apr 2023
Company name: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
Company address: Mindray Building, Keji 12th Road South, High-tech Industrial Park, Nanshan, Shenzhen 518057, P. R. China.

MACHINE
Instrument Code Product Model Product Name
3012B-PA00001 BC-30 Auto Hematology Analyzer
3107B-PA00025 BC-5140 Auto Hematology Analyzer
BC-5390 Auto Hematology Analyzer
3206B-PA00004 BC-6000 Auto Hematology Analyzer
BC-700 & BC-720 Auto Hematology Analyzer
BC-760 & BC-780 Auto Hematology Analyzer
3206B-PA00001 BC-6200 Auto Hematology Analyzer
BA25B-PA00012 BS-230 Clinical Chemistry Analyzer
BA36B-PA00011 BS-240Pro Chemistry Analyzer
BA43B-PA00005 BS-430 Chemistry Analyzer
BA80B-PA00010 BS-800M Chemistry Analyzer
BM10B-PA00001 Cl-2000i Chemiluminescence Immunoassay System
BM60B-PA00001 CL-6000i Chemiluminescence Immunoassay Analyzer
BM50B-PA00001 CL-900i Chemiluminescence Immunoassay System
0104B-PA00003 MR-96A Microplate Reader
0105B-PA00002 MW-12A Microplate Washer
7905B-PA00002 TDR-300B Microorganism Analysis System
7400B-PA00001 TDR-J100 Microorganism Analysis System
7953B-PA00001 TDR-X030 Automated Blood Culture System
7952B-PA00001 TDR-X060 Automated Blood Culture System
7952B-PA00002 TDR-X120 Automated Blood Culture System
8050B-PA00002 TDR-Z200 Automated Blood Culture System
Updated as of April 2023
Company name: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
Company address: Mindray Building, Keji 12th Road South, High-tech Industrial Park, Nanshan, Shenzhen 51805

REAGENTS
Reference Number Product Description
F05CB-PA00002 Semi Cuvettes (including Beads) 350* 2pcs
F05DB-PA00002 Semi Cuvettes (including Beads) 350* 4pcs
043-000644-00 outer-circle
105-006179-00 Angiotensin Converting Enzyme 28ml
105-003177-00 Adenosine Deaminase 60ml
105-000822-00 Albumin 160ml
105-009317-00 Albumin 25ml
105-000816-00 Alkaline Phosphatase 176ml
105-009307-00 Alkaline Phosphatase 35ml
105-000814-00 Alanine Aminotransferase 176ml
105-009305-00 Alanine Aminotransferase 35ml
105-000847-00 α-Amylase 48ml
105-000837-00 Apolipoprotein A1 47ml
105-000838-00 Apolipoprotein B 47ml
105-004629-00 Antistreptolysin "O" 80ml
105-007673-00 Antistreptolysin "O" 80ml
105-000815-00 Aspartate Aminotransferase 176ml
105-009306-00 Aspartate Aminotransferase 35ml
105-004641-00 β2-Microglobulin Ⅱ 52ml
105-004617-00 Complement C3 54ml
105-000840-00 Complement C4 55ml
105-000825-00 Calcium 160ml
105-009319-00 Calcium 25ml
105-001569-00 Cholinesterase 96ml
105-004615-00 Creatine Kinase 88ml
105-009312-00 Creatine Kinase 23ml
105-004616-00 Creatine Kinase-MB 88ml
105-009272-00 Creatine Kinase-MB 30ml
105-001562-00 Carbon dioxide 40ml
105-004614-00 Creatinine 72ml
105-009273-00 Creatinine 30ml
105-000841-00 C-Reactive Protein 50ml
105-009276-00 C-Reactive Protein 25ml
105-004638-00 Cystatin C Ⅱ 52ml
105-000851-00 Bilirubin Direct 100ml
105-000827-00 Bilirubin Direct 176ml
105-009324-00 Bilirubin Direct 30ml
105-006184-00 β-Hydroxybutyrate 24ml
105-001583-00 Iron 96ml
105-006175-00 Ferritin 56ml
105-009261-00 Ferritin 19ml
105-004635-00 Full Range C-Reactive Protein 80ml
105-001576-00 Fructosamine 75ml
105-000817-00 Gamma-Glutamyltransferase 176ml
105-009308-00 Gamma-Glutamyltransferase 35ml
105-000849-00 Glucose 200ml
105-000832-00 Glucose 212ml
105-009313-00 Glucose 35ml
105-006185-00 Glucose-6-Phosphate Dehydrogenase 34ml
105-009264-00 Glucose-6-Phosphate Dehydrogenase 27ml
105-009338-00 Hemoglobin A1c 55ml
105-009339-00 Hemoglobin A1c 55ml
105-000819-00 α-Hydroxybutyrate Dehydrogenase 176ml
105-000835-00 HDL-Cholesterol 54ml
105-009278-00 HDL-Cholesterol 30ml
105-004618-00 Immunoglobulin A 54ml
105-004619-00 Immunoglobulin G 54ml
105-000843-00 Immunoglobulin M 50ml
105-000818-00 Lactate Dehydrogenase 176ml
105-009280-00 Lactate Dehydrogenase 35ml
105-000836-00 LDL-Cholesterol 54ml
105-009279-00 LDL-Cholesterol 30ml
105-001541-00 Lipase 44ml
105-000846-00 Lipoprotein (a) 72ml
105-006173-00 Microalbumin 46ml
105-006174-00 Microalbumin 46ml
105-009258-00 Microalbumin 37ml
105-000834-00 Magnesium 160ml
105-009282-00 Magnesium 25ml
105-000833-00 Phosphorus 160ml
105-009285-00 Phosphorus 25ml
105-000845-00 Prealbumin 55ml
105-006182-00 Retinol Binding Protein 52ml
105-004632-00 Rheumatoid Factor 51ml
105-007676-00 Rheumatoid Factor 51ml
105-004613-00 Total Bile Acids 72ml
105-000850-00 Bil-T(DSA) 100ml
105-000826-00 Bilirubin Total 176ml
105-009323-00 Bilirubin Total 30ml
105-000820-00 Total Cholesterol 160ml
105-009315-00 Total Cholesterol 25ml
105-000821-00 Triglycerides 160ml
105-009316-00 Triglycerides 25ml
105-000823-00 Total protein 4*40ml
105-009318-00 Total protein 1*17ml
105-009168-00 Total Protein in Urine/CSF 54ml
105-006177-00 Transferrin 76ml
105-009262-00 Transferrin 37ml
105-000848-00 Uric acid 200ml
105-009322-00 Uric acid 35ml
105-006187-00 Unsaturated Iron Binding Capacity 24ml
105-009265-00 Unsaturated Iron Binding Capacity 27ml
105-000824-00 Urea 176ml
105-009311-00 Urea 35ml
105-002248-00 Angiotensin Converting Enzyme 40ml
105-003120-00 Adenosine Deaminase 100ml
105-003123-00 α-L-Fucosidase 80ml
105-000861-00 Albumin 240ml
105-000855-00 Alkaline Phosphatase 304ml
105-000853-00 Alanine Aminotransferase 304ml
105-000886-00 α-Amylase 100ml
105-000876-00 Apolipoprotein A1 216ml
105-000877-00 Apolipoprotein B 216ml
105-004630-00 Antistreptolysin "O" 160ml
105-007674-00 Antistreptolysin "O" 160ml
105-000854-00 Aspartate Aminotransferase 304ml
105-004642-00 β2-Microglobulin Ⅱ 104ml
105-000878-00 Complement C3 60ml
105-000879-00 Complement C4 55ml
105-000864-00 Calcium 240ml
105-001570-00 Cholinesterase 192ml
105-000869-00 Creatine Kinase 192ml
105-000870-00 Creatine Kinase-MB 192ml
105-001563-00 Carbon dioxide 80ml
105-000868-00 Creatinine 216ml
105-000880-00 C-Reactive Protein 50ml
105-004639-00 Cystatin C Ⅱ 104ml
105-000890-00 Bilirubin Direct 160ml
105-000866-00 Bilirubin Direct 192ml
105-004497-00 D-Dimer 55ml
105-004513-00 β-Hydroxybutyrate 52ml
105-001584-00 Iron 192ml
105-002244-00 Ferritin 19ml
105-004505-00 Ferritin 19ml
105-004636-00 Full Range C-Reactive Protein 160ml
105-001577-00 Fructosamine 200ml
105-000856-00 Gamma-Glutamyltransferase 304ml
105-000888-00 Glucose 200ml
105-000871-00 Glucose 240ml
105-002254-00 Glucose-6-Phosphate Dehydrogenase 52ml
105-001528-00 Hemoglobin A1c 95ml
105-002166-00 Hemoglobin A1c 95ml
105-005737-00 Hemoglobin A1c 55ml
105-000858-00 α-Hydroxybutyrate Dehydrogenase 304ml
105-000874-00 HDL-Cholesterol 216ml
105-000881-00 Immunoglobulin A 60ml
105-002240-00 Immunoglobulin E 22ml
105-000883-00 Immunoglobulin G 60ml
105-000882-00 Immunoglobulin M 50ml
105-000857-00 Lactate Dehydrogenase 304ml
105-000875-00 LDL-Cholesterol 216ml
105-001542-00 Lipase 50ml
105-000885-00 Lipoprotein (a) 180ml
105-002242-00 Microalbumin 128ml
105-004503-00 Microalbumin 128ml
105-000873-00 Magnesium 240ml
105-004499-00 Myoglobin 35ml
105-000872-00 Phosphorus 240ml
105-000884-00 Prealbumin 55ml
105-004511-00 Retinol Binding Protein 28ml
105-004633-00 Rheumatoid Factor 102ml
105-007677-00 Rheumatoid Factor 102ml
105-000867-00 Total Bile Acids 216ml
105-000889-00 Bil-T(DSA) 160ml
105-000865-00 Bilirubin Total 192ml
105-000859-00 Total Cholesterol 240ml
105-000860-00 Triglycerides 240ml
105-000862-00 Total protein 6*40ml
105-009169-00 Total Protein in Urine/CSF 54ml
105-002246-00 Transferrin 37ml
105-000887-00 Uric acid 304ml
105-004515-00 Unsaturated Iron Binding Capacity 104ml
105-000863-00 Urea 304ml
105-002249-00 Angiotensin Converting Enzyme 80ml
105-003125-00 Adenosine Deaminase 100ml
105-003128-00 α-L-Fucosidase 80ml
105-001597-00 Albumin 360ml
105-004593-00 Alkaline Phosphatase 444ml
105-004591-00 Alanine Aminotransferase 438ml
105-001622-00 α-Amylase 228ml
105-004602-00 Apolipoprotein A1 171ml
105-004603-00 Apolipoprotein B 171ml
105-004631-00 Antistreptolysin "O" 160ml
105-007675-00 Antistreptolysin "O" 160ml
105-004592-00 Aspartate Aminotransferase 438ml
105-004643-00 β2-Microglobulin Ⅱ 104ml
105-001614-00 Complement C3 120ml
105-004604-00 Complement C4 106ml
105-001600-00 Calcium 180ml
105-001571-00 Cholinesterase 192ml
105-004600-00 Creatine Kinase 162ml
105-004601-00 Creatine Kinase-MB 162ml
105-001564-00 Carbon dioxide 120ml
105-004612-00 Creatinine 320ml
105-004605-00 C-Reactive Protein 90ml
105-004640-00 Cystatin C Ⅱ 104ml
105-001626-00 Bilirubin Direct 240ml
105-004599-00 Bilirubin Direct 296ml
105-004498-00 D-Dimer 55ml
105-004514-00 β-Hydroxybutyrate 77ml
105-001585-00 Iron 192ml
105-002245-00 Ferritin 32ml
105-004506-00 Ferritin 32ml
105-004637-00 Full Range C-Reactive Protein 160ml
105-001578-00 Fructosamine 200ml
105-004594-00 Gamma-Glutamyltransferase 438ml
105-001624-00 Glucose 456ml
105-004609-00 Glucose 399ml
105-002255-00 Glucose-6-Phosphate Dehydrogenase 104ml
105-001529-00 Hemoglobin A1c 190ml
105-002167-00 Hemoglobin A1c 190ml
105-005738-00 Hemoglobin A1c 110ml
105-004596-00 α-Hydroxybutyrate Dehydrogenase 216ml
105-004610-00 HDL-Cholesterol 316ml
105-001617-00 Immunoglobulin A 120ml
105-002241-00 Immunoglobulin E 31ml
105-001619-00 Immunoglobulin G 120ml
105-004606-00 Immunoglobulin M 90ml
105-004595-00 Lactate Dehydrogenase 216ml
105-004611-00 LDL-Cholesterol 316ml
105-001543-00 Lipase 100ml
105-004608-00 Lipoprotein (a) 164ml
 105-002243-00 Microalbumin 183ml
105-004504-00 Microalbumin 183ml
105-001609-00 Magnesium 180ml
105-004500-00 Myoglobin 28ml
105-001608-00 Phosphorus 180ml
105-004607-00 Prealbumin 106ml
105-004512-00 Retinol Binding Protein 61ml
105-004634-00 Rheumatoid Factor 102ml
105-007678-00 Rheumatoid Factor 102ml
105-001603-00 Total Bile Acids 244ml
105-001625-00 Bil-T(DSA) 240ml
105-004598-00 Bilirubin Total 296ml
105-001595-00 Total Cholesterol 360ml
105-001596-00 Triglycerides 360ml
105-001598-00 Total protein 6*60ml
105-009170-00 Total Protein in Urine/CSF 80ml
105-002247-00 Transferrin 52ml
105-001623-00 Uric acid 456ml
105-004516-00 Unsaturated Iron Binding Capacity 280ml
105-004597-00 Urea 444ml
115-045559-00 10 seg*8 pcs
115-004016-00 100 pcs
105-000107-00 CD80 Detergent (2 liter*6bottles/box)
040-000542-00 Chloride Electrode (1 pc)
040-000101-00 Cl electrode(1pc)
BA34-10-63645 Cleaning Solution Kit
801-BA80-00164-00 Glass Cuvettes (10pcs)
801-BA80-00219-00 Glass Cuvettes (1pcs)
BA34-10-63641 K electrode(1pc)
105-001688-00 MR Buffer Solution （1 bottle*2 liters)
105-001692-00 MR Detergent Solution (2 bottles*100ml)
105-001689-00 MR Serum Standard(2 bottles*100ml, High, Low)
105-001691-00 MR Urine Quality Control (2 bottles*100ml, High, Low)
105-001690-00 MR Urine Standard (2 bottles*100ml, High, Low)
BA34-10-63640 Na electrode(1pc)
BA34-10-63642 Na+ electrode
040-000541-00 Potassium Electrode (1 pc)
BA30-20-15346 Reagent bottle cap
BA31-20-41536 Reagent bottle cap
BA31-20-41640 Reagent bottle cap
043-000639-00 Reagent bottle(40ml long)
043-000640-00 Reagent bottle(40ml short)
BA34-10-63673 Reagent Module(Cal A,Cal B,Waste)
105-000141-00 Reagent Module(Cal A,Cal B,Waste,Low Throughput)
040-000539-00 Reference Electrode (1 pc)
040-000540-00 Sodium Electrode (1 pc)
BA34-10-63643 Spacer electrode(1pc)
BA34-10-63669 Tri Level Quality Control Kit
BA34-10-63671 Urine Diluent 125ml
105-003687-00 ADA Calibrator 1×1 mL
105-004647-00 CysC Calibrator 5 ×0.5 mL
105-004646-00 CRP Calibrator 5 ×0.5 mL
105-003680-00 HbA1c Calibrator 2×1 mL
105-004648-00 β2-MG Calibrator (for Serum) 5 ×0.5 mL
105-004649-00 β2-MG Calibrator (for Urine) 5 ×0.5 mL
105-001131-00 Lipoprotein(a) Calibrator 3×1 mL
105-001130-00 Prealbumin Calibrator 3×1 mL
105-001132-00 CK-MB Calibrator 3×1 mL
105-001128-00 Lipids Calibrator 5×1 mL
105-001127-00 Multi Sera Calibrator 20×3 mL
105-001144-00 Multi Sera Calibrator 10×3 mL
105-001129-00 Specific Proteins Calibrator 5×1 mL
105-002315-00 MALB calibrator 1×5 levels×1 mL
105-002313-00 ACE calibrator 1×1 level×1 mL
105-002311-00 FER calibrator 1×4 levels×2 mL
105-002319-00 β-HB calibrator 1×1 level×1 mL
105-002309-00 IgE calibrator 1×6 levels×1 mL
105-002302-00 MYO calibrator 1×4 levels×1 mL
105-002304-00 RBP calibrator 1×1 level×1 mL
105-002317-00 TRF calibrator 1×5 levels×1 mL
105-003697-00 ADA Control (L) 1×1 mL
105-003698-00 ADA Control (L) 3×1 mL
105-003699-00 AFU Control （L&H） 1×1 mL; 1×1mL
105-003700-00 AFU Control （L&H） 3×1 mL; 3×1mL
105-009117-00 ClinChem Multi Control (level 1) 10×5 mL
105-009119-00 ClinChem Multi Control (level 1) 6×5 mL
105-009118-00 ClinChem Multi Control (level 2) 10×5 mL
105-009120-00 ClinChem Multi Control (level 2) 6×5 mL
105-004651-00 CysC Control L: 3×1 mL; H: 3×1 mL
105-004650-00 ASO/CRP/RF Triple Control L: 3×1 mL; H: 3×1 mL
105-003695-00 TBA Control (L) 1×5 mL
105-009193-00 TPUC Control L:1×1 ml H:1×1 ml
105-004652-00 β2-MG Control L: 3×1 mL; H: 3×1 mL
105-001143-00 Lipoprotein(a) Control N&P (N)2×1 mL +(P)2×1 mL
105-002143-00 FUN Control P 3×1mL
105-002140-00 HbA1c Control N 4×1mL
105-002138-00 HbA1c Control P 4×1mL
105-001133-00 Multi Control Sera N 20×5 mL
105-001145-00 Multi Control Sera N 10×5 mL
105-001134-00 Multi Control Sera P 20×5 mL
105-001146-00 Multi Control Sera P 10×5 mL
105-002316-00 MALB control 1×1 level×1 mL
105-002314-00 ACE control 1×2 levels×1 mL
105-002301-00 D-Dimer control 1×2 levels×0.5 mL
105-002308-00 G6PD control 1×2 levels×1 mL
105-002320-00 β-HB control 1×2 levels×5 mL
105-002303-00 Multimmun control 1×2 levels×3 mL
105-002305-00 RBPcontrol 1×1 level×1 mL
105-002318-00 TRF control 1×2 levels×1 mL
105-002307-00 UIBC control 1×1 level×5 mL
Activated Partial Thromboplastin Time (APTT) Reagent (Ellagic Acid)
105-006661-00
10 x 2 ml
Activated Partial Thromboplastin Time (APTT) Reagent (Ellagic Acid)
105-006662-00
10 x 4 ml
Antithrombin (AT-III) Assay Kit 8×6ml R1 reagent + 2×3ml R2
105-012846-00 reagent + 1×1ml Calibrator + 1×1ml Quality Control I + 1×1ml Quality
Control II
040-001952-00 Auto cuvettes 5000pcs/box
105-006665-00 Calcium Chloride Solution 10 x 4 ml
105-006676-00 Cleaning Solution I 10 x 15ml
105-006677-00 Cleaning Solution II 1 x 2500ml
105-006674-00 Coagulation Control Plasma I 10 x 1 ml
105-006675-00 Coagulation Control Plasma II 10 x 1 ml
D-Dimer Assay kit 2×6ml DD Buffer + 2×4ml DD Latex + 2×6ml DD
105-006678-00
Diluent
D-Dimer Assay kit 4×6ml DD Buffer + 6×4ml DD Latex + 2×6ml DD
105-006679-00
Diluent
105-006680-00 D-Dimer control Level I: 10 x 1 ml
105-006681-00 D-Dimer control Level II: 10 x 1 ml
105-006673-00 Diluent for coagulation analysis 4 x 50 ml
105-006672-00 Diluent for coagulation analysis 6 x 20 ml
Fibrinogen Assay Kit (FIB) 6×2 ml Thrombin Reagent + 1×1ml
105-006670-00
Fibrinogen Reference Plasma + 2×75ml FIB Buffer
Fibrinogen Assay Kit (FIB) 6×4 ml Thrombin Reagent + 1×1ml
105-006671-00
Fibrinogen Reference Plasma + 2×75ml FIB Buffer
105-006658-00 Prothrombin Time Reagent(PT) 10 x 2 ml
105-006659-00 Prothrombin Time Reagent(PT) 10 x 4 ml
105-006667-00 Thrombin Time Reagent(TT) 10 x 2 ml
105-006668-00 Thrombin Time Reagent(TT) 10 x 5 ml
105-009404-00 B30 6 x 3.0ml Single-pack(6L)
105-009408-00 TDR NF-96
105-009418-00 TDR NH-96
105-009393-00 TDR ONE-96
105-006858-00 TDR Resin Aerobic (1×25)
105-006860-00 TDR Resin Anaerobic (1×25)
105-006857-00 TDR Resin Peds (1×25)
105-009398-00 TDR STAPH-96
105-009413-00 TDR STR-96
105-009403-00 TDR YEAST-96
105-012741-00 M-10CFL Lyse 100ml×4/box
105-012742-00 M-10CFL Lyse 200ml×4/box
105-012744-00 M-10CFL Lyse 500ml
A12-000132--- M-18CFL Lyse 500ml
A12-000134--- M-18D Diluent 20L
A12-000135--- M-18D Diluent 5.5L×2
A12-000138--- M-18E E-Z cleanser 100ml
A12-000139--- M-18P Probe cleanser 17ml x 12
A12-000137--- M-18R Rinse 20L
A12-000136--- M-18R Rinse 5.5L×2
105-012726-00 M-20CFL Lyse 100ml×4/box
105-012727-00 M-20CFL Lyse 200ml×4/box
105-012731-00 M-20CFL Lyse 500ml
A12-000159--- M-23CFL Lyse 250ml
A12-000160--- M-23CFL Lyse 500ml
A12-000249--- M-23D Diluent 10L
A12-000155--- M-23D Diluent (20L/tank) 20L
A12-000162--- M-23E E-Z cleanser 50ml
A12-000164--- M-23P Probe cleanser 17ml x 12
M-30 Reagent kit MINI Pack Including:
105-006211-00 Diluent (5.5L/tank)
CFL Lyse (100ml/bottle)
105-006209-00 M-30CFL Lyse 100ml×4/box
105-006210-00 M-30CFL Lyse 200ml×4/box
A12-000083--- M-30CFL Lyse 250ml
A12-000084--- M-30CFL Lyse 500ml
A12-000047--- M-30D Diluent 20L
A12-000042--- M-30D Diluent 5.5L×2
A12-000045--- M-30E E-Z cleanser 100ml
A12-000046--- M-30P Probe cleanser 17ml x 12
A12-000048--- M-30R Rinse 20L
A12-000043--- M-30R Rinse 5.5L×2
105-004891-00 C-reactive Protein Latex 25mL x 2
105-004887-00 LC lyse 200ml x 1
105-011724-00 M-5 LEO (I) Lyse 1L x 4
105-011725-00 M-5 LEO (I) Lyse 4L x 1
105-011730-00 M-5 LEO (II) Lyse 1L x 4
105-011729-00 M-5 LEO (II) Lyse 500ml x 4
105-011735-00 M-53 LH Lyse 1L x 4
105-011734-00 M-53 LH Lyse 500ml x 4
105-011736-00 M-53D Diluent 20L×1
105-004045-00 M-52D Diluent 20L×1
105-003724-00 M-52DIFF Lyse 500mL×4
105-004461-00 M-52DIFF Lyse 500mL×1
105-004307-00 M-52LH Lyse 100mL×4
105-004463-00 M-52LH Lyse 100mL×1
A11-000134--- M-53 Cleanser 1L×4
A11-000136--- M-53D Diluent 20L
A11-000128--- M-53LEO(I) lyse 1L×4
A11-000129--- M-53LEO(I) lyse 4L
A11-000130--- M-53LEO(II) lyse 200ml×4
A11-000131--- M-53LEO(II) lyse 400ml×4
A11-000133--- M-53LH lyse 1L×4
A11-000132--- M-53LH lyse 500ml×4
003D-30-84194 M-53P Probe cleanser 50ml
105-000414-00 M-58 Cleanser 1L×4
105-001660-00 M-58 LEO (I) Lyse 4L/bottle
105-000403-00 M-58D Diluent 20L
105-000418-00 M-58LBA lyse 1L×4
105-001663-00 M-58LBA lyse 4L/box
105-000415-00 M-58LEO(I) lyse 1L×4
105-001661-00 M-58LEO(II) lyse 1L×4/box
105-000416-00 M-58LEO(II) lyse 500ml×4
105-001662-00 M-58LH lyse 3L*1/box
105-000417-00 M-58LH lyse 500ml×4
105-000405-00 Probe cleanser 50ml
105-012283-00 DS Diluent 20L
105-012286-00 M-6 DR DILUENT 1L×4
105-012285-00 M-6 DR DILUENT 4L×1
105-012298-00 M-6 FD Dye 12mL×4
105-012297-00 M-6 FD Dye 48mL×1
105-012294-00 M-6 FN Dye 12mL×4
105-012293-00 M-6 FN Dye 48mL×1
105-012296-00 M-6 FR Dye 12mL×4
105-012295-00 M-6 FR Dye 48mL×1
105-012288-00 M-6 LD Lyse 1L×4
105-012287-00 M-6 LD Lyse 4L×1
105-012292-00 M-6 LH Lyse 1L×4
105-012291-00 M-6 LH Lyse 4L×1
105-012290-00 M-6 LN Lyse 1L×4
105-012289-00 M-6 LN Lyse 4L×1
105-002025-00 M-68DR Diluent 1L×4
105-001975-00 M-68DR Diluent 4L×1
105-001974-00 M-68DS Diluent 20L
105-002233-00 M-68FD Dye 12mL×4
105-001993-00 M-68FD Dye 48mL×1
105-001987-00 M-68FN Dye 48mL×1
105-002231-00 M-68FN Dye 12mL×4
105-001990-00 M-68FR Dye 48mL×1
105-002232-00 M-68FR Dye 12mL×4
105-002028-00 M-68LB Lyse 1L×4
105-001981-00 M-68LB Lyse 4L×1
105-001977-00 M-68LD Lyse 4L×1
105-002026-00 M-68LD Lyse 1L×4
105-001983-00 M-68LH Lyse 4L×1
105-002029-00 M-68LH Lyse 1L×4
105-002027-00 M-68LN Lyse 1L×4
105-001979-00 M-68LN Lyse 4L×1
105-002020-00 M-68NRBC Kit M-68LN Lyse 1L×1 & M-68FN Dye 12mL×1
105-002021-00 M-68RET Kit M-68DR Diluent 1L×1 & M-68FR Dye 12mL×1
105-002225-00 Probe Cleanser 50ml
040-001496-00 SC-CAL PLUS 1×3.0m
003C-30-83703 SC-CAL PLUS 2×3.0m
105-006660-00 List Price上找不到
105-006666-00 List Price上找不到
040-000010-00 BC-3D 3 x 3.0ml Tri-pack(1L, 1N, 1H)
003C-30-83715 BC-3D 6 x 3.0ml Single-pack(6 High)
003C-30-83713 BC-3D 6 x 3.0ml Single-pack(6 Low)
003C-30-83714 BC-3D 6 x 3.0ml Single-pack(6 Normal)
040-000009-00 BC-3D 6 x 3.0ml Tri-pack(2L, 2N, 2H)
040-000024-00 BC-5D 12 x 3ml Single-pack(12 High)
040-000025-00 BC-5D 12 x 3ml Single-pack(12 Low)
040-000023-00 BC-5D 12 x 3ml Single-pack(12 Normal)
040-000022-00 BC-5D 12 x 3ml Tri-pack(4L, 4N, 4H)
040-000020-00 BC-5D 6 x 3.0ml Single-pack(6 High)
040-000021-00 BC-5D 6 x 3.0ml Single-pack(6 Low)
040-000019-00 BC-5D 6 x 3.0ml Single-pack(6 Normal)
040-000018-00 BC-5D 6 x 3.0ml Tri-pack(2L, 2N, 2H)
040-001484-00 BC-6D 6 x 4.5ml Single-pack(6 High)
040-001486-00 BC-6D 6 x 4.5ml Single-pack(6 Low)
040-001485-00 BC-6D 6 x 4.5ml Single-pack(6 Normal)
040-001487-00 BC-6D 6 x 4.5ml Tri-pack(2L, 2N, 2H)
105-012907-00 BC-BF 3.0ml x 3(1L1N1H)
105-012908-00 BC-BF 3.0ml x 6(2L2N2H)
040-001492-00 BC-RET 6 x 4.5ml Single-pack(6 High)
040-001494-00 BC-RET 6 x 4.5ml Single-pack(6 Low)
040-001493-00 BC-RET 6 x 4.5ml Single-pack(6 Normal)
040-001495-00 BC-RET 6 x 4.5ml Tri-pack(2L, 2N, 2H)
M30-000015--- TP Thermo Printing Paper (1 Roll)
0103-30-61161 U-11 Urine reagent strips (50 can/carton)