Bio-Rad Laboratories
Bio-Rad Laboratories holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2019, with 3 FDA device recalls on record.
Top product codes for Bio-Rad Laboratories
FDA recalls by Bio-Rad Laboratories
- Z-1358-2024 — Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
- Z-0032-2014 — FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
- Z-2398-2012 — The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Bio-Rad Laboratories
- K183446 — BioPlex 2200 Lyme Total
- K180577 — BioPlex 2200 25-OH Vitamin D Kit
- K170509 — BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
- K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
- K163015 — Liquichek Tumor Marker Control-Level 1 +3 more
- K152679 — Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
- DEN150058 — Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak
- K150300 — Liquichek Cardiac Markers Plus Control LT
- K143379 — Liquichek Maternal Serum II Control
- K141114 — BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D
- K141073 — LIQUICHEK TUMOR MARKER CONTROL
- K140916 — LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
- K140764 — LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK
- K134013 — LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO
- K133960 — LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
- K132227 — LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY
- K130528 — BIOPLEX 2200 APLS IGM
- K130761 — LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK
- K130162 — LIQUID ASSAYED MULTIQUAL PREMIUM
- K123775 — LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK
- K123798 — LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
- K123663 — LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
- K123198 — LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA
- K123021 — BIOPLEX 2200 EBV IGM KIT
- K122838 — LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK
- K113610 — ANA-SCREEN WITH MDSS
- K120959 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
- K121143 — LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
- K103834 — BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
- K112810 — MULTI-ANALYTE DETECTION SYSTEMS
- K111072 — BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL
- K092587 — BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM
- K093954 — BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K091303 — LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
- K091616 — BIOPLEX 2200 MMRV IGG
- K093577 — LIQUICHEK OPIATE CONTROL
- K090847 — PLATELIA TOXO IGM KIT MODEL 26211
- K090409 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K082036 — LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK
- K073080 — QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
- K072358 — BIOPLEX VASCULITIS KIT
- K071675 — LIQUICHEK TUMOR MARKER CONTROL
- K063318 — MONOLISA ANTI-HAV EIA
- K063319 — MONOLISA ANTI-HAV IGM EIA
- K070546 — LYPHOCHEK DIABETES CONTROL
- K063866 — BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.