Bio-Rad Laboratories (Singapore) Pte. Ltd.

FDA Device Registration & Listing · Singapore Central Singapore, SG · Registration 3006421415

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006421415
FEI Number
3006421415
Entity Name
Bio-Rad Laboratories (Singapore) Pte. Ltd.
City/State/Country
Singapore Central Singapore, SG
Establishment Address
1 Kaki Bukit View, #03-01 & #05-01 Techview, Singapore Central Singapore 415941, SG
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Bio-Rad Laboratories, Inc. (Owner Number: 9929003)
Owner / Operator Contact Address
4000 Alfred Nobel Drive, --, Hercules, CA 94547, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

VARIANT II Turbo Hemoglobin Testing System D-100 Hemoglobin Testing System IH-500 IH-Reader 24 D-10 Hemoglobin A1c Program D-10 Hemoglobin Testing System PhD lx System PhD lx Workstation PhD System IH-500 IH-Reader 24 IH-Incubator L IH-Centrifuge L PW41 Microplate Washer IH-500 Analyzer IPS Microplate incubator

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2014-11-12
PDJ Hemoglobin A1c Test System Clinical Chemistry Class 2 862.1373 2015-12-16
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2022-09-22
PDJ Hemoglobin A1c Test System Clinical Chemistry Class 2 862.1373 2016-12-09
JQW Station, Pipetting And Diluting, For Clinical Use Clinical Chemistry Class 1 862.2750 2011-11-23
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2023-08-31
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2022-12-02
PBC Manual Blood Grouping And Antibody Test Systems Hematology Class 2 864.9175 2022-12-02
JTC Device, Microtiter Diluting/Dispensing Microbiology Class 1 866.2500 2022-10-21
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2023-02-10
JRR Regulator, Temperature Clinical Chemistry Class 1 862.2050 2022-12-05

Official Correspondent

Elizabeth Platt

US Agent Details

Jackie Buckley Business: Bio-Rad Laboratories Inc. Email: jackie_buckley@bio-rad.com Phone: (510) 4107695

Related Public Records

Same Entity

Bio-Rad Laboratories, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3032023483 Bio-Rad Laboratories (S) Pte Ltd Singapore South West, SG
3011926203 EXACT DIAGNOSTICS Fort Worth, TX, US
2016706 Bio-Rad Laboratories Inc. IRVINE, CA, US
3010127294 Bio-Rad Laboratories Inc. Irvine, CA, US
2915274 Bio-Rad Laboratories, Inc. Hercules, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K935876 Bio-Rad Laboratories, Inc. ACCESS SPECIFIC IGE ASSAY 1994-03-11
K920820 Helena Laboratories MODIFICATION COLUMNMATE 1992-08-17
K991850 Biosafe Laboratories, Inc. SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC 1999-11-26
K171771 Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay 2017-12-04
K851403 Ventrex Laboratories, Inc. VENTREZYME ALLERGEN DATA REDUCTION SYSTEM 1985-06-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer 3. Wash/Diluent 1 x 1600 mL Deionized water 4. Analytical cartridge - 1 cation exchange cartridge 5. Floppy Diskette 1-program parameters 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid 9 Thermal paper - 1 roll 10. Instruction manual Made in United States Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0018-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0019-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0020-2012 Bio-Rad Laboratories, Inc. 2
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0021-2012 Bio-Rad Laboratories, Inc. 2
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 3 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006421415. Last updated year: 2026. Please use registration number 3006421415 when referencing this establishment in official correspondence.
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