Bio-Rad Laboratories Inc.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3010127294

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
3010127294
FEI Number
3010127294
Entity Name
Bio-Rad Laboratories Inc.
City/State/Country
Irvine, CA, US
Establishment Address
9 Holland, Irvine, CA 92618, US
Establishment Type(s)
Manufacture Medical 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
K143379
PMA Number
N/A

All Registered Proprietary Names

Liquichek Immunoassay Premium Control VIROTROL HIV-2 Quest Diagnostics Tumor Marker VIROTROL IV Lyphochek Whole Blood Control Liquichek Autoimmune Control, Anti-Mitochondrial Liquichek Autoimmune Control, Anti-Scl-70 Liquichek Autoimmune Control, Anti-RNP Liquid Assayed Multiqual (Vista) VIROTROL III Lyphochek Maternal Serum Control Liquichek Hematology-16T Control Liquichek Reticulocyte Control (C) Meter Trax Control VIROTROL II Liquichek ANA Controls Set, Positive: Homogenous, Speckled, Centromere and Nucleolar Patterns Lyphochek Tumor Marker Control Liquichek Urine Toxicology Control, Confirmatory, C2, C2 Low Opiate, C3, C3 Low Opiate, C4 Liquichek Autoimmune Negative Control Liquichek Blood Gas Plus CO-Oximeter (IL Synthesis Series) Lyphochek Drug Free Serum Liquichek Rheumatoid Factor Control Liquichek Hematology-16 Control Lyphochek Fertility Control Serum Liquichek Reticulocyte Control (A-1) VIROTROL I Lyphochek Allergen sIgE Control, Negative Lyphochek Allergen sIgE Control, Panel A Lyphochek Therapeutic Drug Monitoring Control Liquichek Urine Toxicology Control, S1O, S2O, S1O Low Opiate, S2O Low Opiate Liquichek Ethanol/Ammonia Control (Vista) Lyphochek Urine Metals Control Liquichek Tumor Marker Control Liquichek Spinal Fluid Control Liquichek Blood Gas CO-Oximeter Control (Radiometer) Lyphochek Tumor Marker Plus Control Liquichek ANA Control, Homogeneous Positive Liquichek Diabetes Control (171, 172, 173, 172X) Virotrol III Liquichek Pediatric Control Lyphochek Benzo/TCA Control Set B Quest Diagnostics Immunoassay/TDM Control Liquichek Autoimmune, Anti-Sm Lyphochek Assayed Chemistry Control qUAntify Plus Control Quantify Advance Control qUAntify Control Liquichek Cardiac Markers Plus Control LT (Vista) Liquichek Cardiac Markers Plus Control Lyphochek Hemoglobin A2 Control Liquichek Serum Volatiles Control Liquichek Blood Gas Control Liquichek Blood Gas Plus CO-Oximeter Control Lyphochek Whole Blood Metals Control Liquichek Elevated CRP Control Liquichek AMH Control Liquichek D-dimer Control Lyphochek Urine Toxicology Control Liquichek Urine Toxicology Negative Control Lyphochek Anemia Control Liquichek Urine Toxicology Control, Screen - S1S and S2S Liquichek Immunoassay Plus Control InteliQ Immunoassay Plus Control Liquichek Blood Gas Plus EGL Control Liquichek Diabetes Control (171, 172, 173, 172X) InteliQ Diabetes Control (12008309, 12008310, 12008311, 12008312) Liquichek Diabetes Control (12011343, 12011344,12011345, 12011334) Liquichek Diabetes Control (12011308, 12011309,12011310, 12011331) Liquichek Hematology Control (A) Liquichek Whole Blood Immunosuppressant Control Liquichek Autoimmune, Anti-SS-B Liquichek CK/LD Isoenzyme Control Liquichek Pediatric Control (Vista) Liquichek Immunology Control (Vista) Liquichek Qualitative Urine Toxicology Control Liquichek Cardiac Markers LT Control (1, 2, 3, Low ) Lyphochek Whole Blood Immunosuppressant Control Liquichek Cardiac Markers Plus InteliQ Cardiac Markers Plus Control LT InteliQ Cardiac Advance Control Liquichek Cardiac Advance Control Liquichek Cardiac Markers Plus Control LT 1, 2, 3 and Low Liquichek Reticulocyte Control (S) Liquichek Reticulocyte Control (A) Liquid Assayed Multiqual, InteliQ Assayed Muliqual Control Liquichek Urinalysis Control Lyphochek Quantitative Urine Control, Normal Liquichek ANA Control, Speckled Positive VIROCLEAR Lyphochek Hemostasis Control VIROTROL TORCH Lyphochek Coagulation Control Liquichek Tumor Marker Control (Vista) Lyphochek Specialty Immunoassay Control Liquichek Lipids Control Liquichek Autoimmune Control, Anti-Smooth Muscle Lyphochek Immunolgy Plus Control Liquichek Hematology Control (X) VIROTROL HIV-1 Ag Amplichek II Lyphochek Immunoassay Plus Control Liquichek Immunology Control InteliQ Immunology Control Lyphochek Hypertension Markers Control Liquichek Homocysteine Control InteliQ Homocysteine Control Liquichek Urine Toxicology Control, Confirmatory C1 Liquichek Maternal Serum II Control Liquichek Maternal Serum First Trimester Control

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-12-16
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2008-01-29
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-03
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-01-29
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-03
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2008-01-28
LKJ Antinuclear Antibody, Antigen, Control Immunology Class 2 866.5100 2008-01-28
LKJ Antinuclear Antibody, Antigen, Control Immunology Class 2 866.5100 2008-01-28
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-01-12
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2008-01-29
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-01-25
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2011-01-12
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2013-03-19
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-23
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2008-06-23
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2011-06-13
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2016-09-12
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-09
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2008-04-11
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2008-01-28
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-06-04
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2008-04-11
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2008-04-11
JCN Control, Cell Counter, Normal And Abnormal Hematology Class 2 864.8625 2008-01-28
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-04-11
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2010-08-03
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2008-01-29
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2014-04-25
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2008-04-11
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2012-09-19
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-02-19
DIE Heavy Metals Control Materials Clinical Toxicology Class 1 862.3280 2008-01-17
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-09
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-23
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-06-04
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-04-14
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2008-01-28
GGM Control, Hemoglobin Hematology Class 2 864.8625 2008-01-25
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-06-13
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-01-25
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2008-06-23
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-03
LKP Anti-Sm Antibody, Antigen And Control Immunology Class 2 866.5100 2008-01-28
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-23
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-06-04
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-02-19
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2016-04-19
JCM Control, Hemoglobin, Abnormal Hematology Class 2 864.7415 2008-06-20
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-01-25
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-06-04
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-06-09
DIE Heavy Metals Control Materials Clinical Toxicology Class 1 862.3280 2008-04-11
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-04-11
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-03-01
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2008-04-11
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2016-12-02
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2008-04-11
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-04-11
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2008-04-11
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-20
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-06-09
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-02-19
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2010-08-03
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2012-09-19
LKJ Antinuclear Antibody, Antigen, Control Immunology Class 2 866.5100 2008-01-28
JJT Enzyme Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-06-23
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-05-13
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-04-16
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2008-04-11
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-23
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2008-06-20
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-01-25
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2010-08-03
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2013-03-19
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-23
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-04-11
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-06-20
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2008-01-28
MYZ Kit, Test (Donors), For Bloodborne Pathogen Unknown Class 2 N/A 2008-01-29
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2008-06-09
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-01-29
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2008-06-23
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2014-08-11
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2014-03-12
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-20
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2008-01-28
DAK Complement C1q, Antigen, Antiserum, Control Immunology Class 2 866.5240 2008-11-11
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2013-03-21
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2008-01-29
PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays Microbiology Class 2 866.3920 2016-04-19
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-04-11
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-09
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-09
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-06-23
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2008-04-11
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2015-07-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3006421415 Bio-Rad Laboratories (Singapore) Pte. Ltd. Singapore Central Singapore, SG
2016706 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
K990531 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS 1999-03-12
K982637 Diagnostic Products Corp. IMMULITE PSA CONTROL MODULE, MODEL LPSCM 1998-08-12
K012468 Dade Behring, Inc. MODIFICATION TO N/T PROTEIN CONTROL SL 2001-09-04
K880742 Inova Diagnostics, Inc. NOVA LITE(TM) DSDNA 1988-03-25

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 3010127294. Last updated year: 2026. Please use registration number 3010127294 when referencing this establishment in official correspondence.
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