BIO-RAD LABORATORIES

PMA#

• BIO-RAD MONOLISA ANTI-HBS EIA

  2013-12-12

  BIO-RAD LABORATORIES

• BIO-RAD MONOLISA ANTI-HBS EIA

  2012-11-13

  BIO-RAD LABORATORIES

• BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT

  2012-11-13

  BIO-RAD LABORATORIES

• BIO-RAD MONOLISA ANTI-HBS EIA

  2011-04-25

  BIO-RAD LABORATORIES

• MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT

  2010-11-23

  BIO-RAD LABORATORIES

• BIO-RAD MONOLISA ANTI -HBS EIA

  2010-09-27

  BIO-RAD LABORATORIES

• BIO-RAD MONOLISA ANTI-HBS EIA

  2010-03-12

  BIO-RAD LABORATORIES

• BIO-RAD MONOLISA ANTI-HBS EIA & ANTI-HBS CALIBRATOR KIT

  2008-07-17

  BIO-RAD LABORATORIES

• MONOLISA ANTI-HBS EIA

  2006-08-25

  BIO-RAD LABORATORIES

PMN#

• BioPlex 2200 Lyme Total

  2019-03-12

  Bio-Rad Laboratories

• BioPlex 2200 25-OH Vitamin D Kit

  2018-06-22

  Bio-Rad Laboratories

• BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

  2017-05-19

  Bio-Rad Laboratories

• BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set

  2017-05-11

  Bio-Rad Laboratories

• Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak

  2017-01-10

  BIO-RAD LABORATORIES

• Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak

  2016-05-10

  BIO-RAD LABORATORIES

• Liquichek Cardiac Markers Plus Control LT

  2015-12-11

  Bio-Rad Laboratories

• 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

  2015-07-23

  Bio-Rad Laboratories

• Liquichek Maternal Serum II Control

  2015-03-13

  Bio-Rad Laboratories

• 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

  2015-01-09

  Bio-Rad Laboratories

• LIQUICHEK TUMOR MARKER CONTROL

  2014-06-23

  Bio-Rad Laboratories

• LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK

  2014-05-06

  Bio-Rad Laboratories

• LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK

  2014-04-25

  Bio-Rad Laboratories

• LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO

  2014-04-24

  Bio-Rad Laboratories

• LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL

  2014-01-22

  Bio-Rad Laboratories

• LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY

  2013-10-25

  Bio-Rad Laboratories

• BIOPLEX 2200 APLS IGM

  2013-10-21

  Bio-Rad Laboratories

• LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK

  2013-04-12

  Bio-Rad Laboratories

• LIQUID ASSAYED MULTIQUAL PREMIUM

  2013-03-01

  Bio-Rad Laboratories

• LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK

  2013-01-31

  Bio-Rad Laboratories

• LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK

  2013-01-09

  Bio-Rad Laboratories

• LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK

  2012-12-27

  Bio-Rad Laboratories

• LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA

  2012-11-20

  Bio-Rad Laboratories

• BIOPLEX 2200 EBV IGM KIT

  2012-11-02

  Bio-Rad Laboratories

• LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK

  2012-10-17

  Bio-Rad Laboratories

• ANA-SCREEN WITH MDSS

  2012-07-09

  Bio-Rad Laboratories

• BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT

  2012-06-22

  Bio-Rad Laboratories

• LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)

  2012-05-18

  Bio-Rad Laboratories

• BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS

  2012-03-30

  Bio-Rad Laboratories

• MULTI-ANALYTE DETECTION SYSTEMS

  2011-10-26

  Bio-Rad Laboratories

• BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL

  2011-08-23

  Bio-Rad Laboratories

• BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM

  2010-12-03

  Bio-Rad Laboratories

• BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

  2010-08-24

  Bio-Rad Laboratories

• LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV

  2010-08-02

  Bio-Rad Laboratories

• BIOPLEX 2200 MMRV IGG

  2010-03-29

  Bio-Rad Laboratories

• LIQUICHEK OPIATE CONTROL

  2010-03-12

  Bio-Rad Laboratories

• PLATELIA TOXO IGM KIT MODEL 26211

  2009-07-01

  Bio-Rad Laboratories

• BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

  2009-05-08

  Bio-Rad Laboratories

• LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK

  2008-09-08

  Bio-Rad Laboratories

• QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945

  2008-01-24

  Bio-Rad Laboratories

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