Bio-Rad Laboratories (S) Pte Ltd

FDA Device Registration & Listing · Singapore South West, SG · Registration 3032023483

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
3032023483
FEI Number
3032023483
Entity Name
Bio-Rad Laboratories (S) Pte Ltd
City/State/Country
Singapore South West, SG
Establishment Address
2 Pioneer, Sector 1 #04-01/02, Singapore South West 628414, SG
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
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

Geenius Reader BioPlex 2200 CFX Opus 96 Dx CFX Opus 384 Dx CFX Opus Deepwell Dx CFX96 Deep Well Dx System CFX96 Dx System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2022-11-08
NSU Instrumentation For Clinical Multiplex Test Systems Clinical Chemistry Class 2 862.2570 2020-03-13

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
3011926203 EXACT DIAGNOSTICS Fort Worth, TX, US
3006421415 Bio-Rad Laboratories (Singapore) Pte. Ltd. Singapore Central Singapore, SG
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

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 3032023483. Last updated year: 2026. Please use registration number 3032023483 when referencing this establishment in official correspondence.
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