FDA Registration
Active
🇺🇸 United States
Bio-Rad Laboratories Inc.
Reg #: 3010127294
·
FEI: 3010127294
·
Expires 2026
Products
21
Proprietary Names
144
Establishment Types
3
Classifications
21
Registration Details
- Registration Name
- Bio-Rad Laboratories Inc.
- Registration Number
- 3010127294
- FEI Number
- 3010127294
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9 Holland
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K132227
Owner / Operator
- Firm Name
- Bio-Rad Laboratories, Inc.
- Operator Number
- 9929003
- Address
- 4000 Alfred Nobel Drive, --
- City
- Hercules
- State
- CA
- Postal Code
- 94547
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2013-12-16 |
| Kit, Quality Control For Blood Banking Reagents | KSF | Class 2 | Hematology | No | 2008-01-29 |
| Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | DHN | Class 2 | Immunology | No | 2008-01-28 |
| Antinuclear Antibody, Antigen, Control | LKJ | Class 2 | Immunology | No | 2008-01-28 |
| Mixture, Hematology Quality Control | JPK | Class 2 | Hematology | No | 2011-01-12 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2008-04-11 |
| Controls For Blood-Gases, (Assayed And Unassayed) | JJS | Class 1 | Clinical Chemistry | No | 2008-06-04 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2008-04-11 |
| Control, Cell Counter, Normal And Abnormal | JCN | Class 2 | Hematology | No | 2008-01-28 |
| Heavy Metals Control Materials | DIE | Class 1 | Clinical Toxicology | No | 2008-01-17 |
| Control, Hemoglobin | GGM | Class 2 | Hematology | No | 2008-01-25 |
| Anti-Sm Antibody, Antigen And Control | LKP | Class 2 | Immunology | No | 2008-01-28 |
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2008-06-04 |
| Control, Hemoglobin, Abnormal | JCM | Class 2 | Hematology | No | 2008-06-20 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2008-04-11 |
| Plasma, Coagulation Control | GGN | Class 2 | Hematology | No | 2008-04-11 |
| Enzyme Controls (Assayed And Unassayed) | JJT | Class 1 | Clinical Chemistry | No | 2008-06-23 |
| Kit, Test (Donors), For Bloodborne Pathogen | MYZ | Class 2 | Unknown | No | 2008-01-29 |
| Complement C1q, Antigen, Antiserum, Control | DAK | Class 2 | Immunology | No | 2008-11-11 |
| Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | PMN | Class 2 | Microbiology | No | 2016-04-19 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2014-05-19 |
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
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
Liquichek ANA Control, Centromere Positive
Liquichek Urine Chemistry Control (2.5 mL vials) and Liquichek Urine Chemistry Control (Tubes)
InteliQ Urine Chemistry Control
Liquichek Urine Chemistry Control
Liquichek Opiate Control
Liquichek Therapeutic Drug Monitoring Control (TDM)
Liquichek Immunoassay Plus Control (Vista)
Liquichek Autoimmune Control, Anti-nDNA
Liquichek Spinal Fluid Control (Vista)
Beckman Coulter Lyophilized Chemistry Calibrator 1 and 2
Liquid Assayed Multiqual Premium
Liquichek ANA Control, Mitotic Spindle, Positive
Liquichek Urine Toxicology Control, Screen EIA S1E and S2E Low Opiate and S1E and S2E
Lyphochek Diabetes Control
Liquichek Ethanol/Ammonia Control
InteliQ Ethanol/Ammonia Control
Liquichek Blood Gas Plus E Control
Liquichek ToRCH Plus IgM Control
Lyphochek Hemoglobin A1C Linearity Set
Liquichek Microalbumin Control
Liquichek ANA Control, Nucleolar Positive
Liquichek Hematology Control (S)
Liquichek Autoimmune Control, Anti-SS-A
Liquichek Hematology Control (C)
Lyphochek Quantitative Urine Control, Abnormal
Liquichek Reticulocyte Control (X)
Liquichek Urine Toxicology Control Screen S1, S2, S3
InteliQ Specialty Immunoassay Control
Liquichek Specialty Immunoassay Plus Control
InteliQ Specialty Immunoassay Plus Control
Liquichek Specialty Immunoassay Control
Quest Diagnostics Serum Chemistry Control
Liquichek Cardiac Troponins Control
Lyphochek Urine Bone Markers Control
InteliQ Tumor Marker Control,
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)