K960850 |
03/01/1996 |
ACCESS CHLAMYDIA ASSAY |
BIO-RAD LABORATORIES, INC. |
K954687 |
10/11/1995 |
ACCESS RUBELLA IGG |
BIO-RAD LABORATORIES, INC. |
K041658 |
06/18/2004 |
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 |
BIO-RAD LABORATORIES, INC. |
K043341 |
12/03/2004 |
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
BIO-RAD LABORATORIES, INC. |
K080008 |
01/02/2008 |
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET |
BIO-RAD LABORATORIES, INC. |
K062211 |
08/01/2006 |
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
BIO-RAD LABORATORIES, INC. |
K062213 |
08/01/2006 |
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
BIO-RAD LABORATORIES, INC. |
K955435 |
10/02/1995 |
ACCESS TOTAL T3 ASSAY (MODIFICATION) |
BIO-RAD LABORATORIES, INC. |
K955436 |
10/02/1995 |
ACCESS VITAMIN B12 ASSAY (MODIFICATION) |
BIO-RAD LABORATORIES, INC. |
K960913 |
03/06/1996 |
ACCESS FREE T3 ASSAY |
BIO-RAD LABORATORIES, INC. |
K955769 |
12/21/1995 |
ACCESS PROGESTERONE ASSAY |
BIO-RAD LABORATORIES, INC. |
K140801 |
03/31/2014 |
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM |
BIO-RAD LABORATORIES, INC. |
K040273 |
02/05/2004 |
LYPHOCHEK ASSAYED CHEMISTRY CONTROL |
BIO-RAD LABORATORIES, INC. |
K120504 |
02/21/2012 |
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK |
BIO-RAD LABORATORIES, INC. |
K020817 |
03/13/2002 |
LIQUICHEK URINE CHEMISTRY CONTROL |
BIO-RAD LABORATORIES, INC. |
K050682 |
03/16/2005 |
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) |
BIO-RAD LABORATORIES, INC. |
K033924 |
12/18/2003 |
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) |
BIO-RAD LABORATORIES, INC. |
K060001 |
01/03/2006 |
D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM |
BIO-RAD LABORATORIES, INC. |
K031043 |
04/01/2003 |
D-10 HEMOGLOBIN A1C |
BIO-RAD LABORATORIES, INC. |
K040872 |
04/02/2004 |
VARIANT II HEMOGLOBIN A1C |
BIO-RAD LABORATORIES, INC. |
K151321 |
05/18/2015 |
D-100 HbA1c, D-100 HbA1c Calibrator Pack |
Bio-Rad Laboratories, Inc. |
K041444 |
06/01/2004 |
BIO-RAD D-10 DUAL PROGRAM |
BIO-RAD LABORATORIES, INC. |
K161687 |
06/17/2016 |
D-10 Hemoglobin A1c Program |
BIO-RAD LABORATORIES, INC. |
K142448 |
09/02/2014 |
VARIANT II TURBO HbA1c Kit - 2.0 |
Bio-Rad Laboratories, Inc. |
K063400 |
11/09/2006 |
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 |
BIO-RAD LABORATORIES, INC. |
K070452 |
02/16/2007 |
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU |
BIO-RAD LABORATORIES, INC. |
K090699 |
03/17/2009 |
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 |
BIO-RAD LABORATORIES, INC. |
K963934 |
10/01/1996 |
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 |
BIO-RAD LABORATORIES, INC. |
K090737 |
03/20/2009 |
HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI |
BIO-RAD LABORATORIES, INC. |
K130053 |
01/15/2013 |
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI |
BIO-RAD LABORATORIES, INC. |
K120439 |
02/13/2012 |
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG |
BIO-RAD LABORATORIES, INC. |
K120572 |
02/27/2012 |
BIOPLEX 2200 TORC IGG |
BIO-RAD LABORATORIES, INC. |
K092353 |
08/04/2009 |
MONOLISA ANTI-HAV IGM EIA |
BIO-RAD LABORATORIES, INC. |
K092355 |
08/04/2009 |
MONOLISA ANTI-HAV EIA |
BIO-RAD LABORATORIES, INC. |
K040822 |
03/30/2004 |
LIQUICHEK TORCH PLUS IGM CONTROL |
BIO-RAD LABORATORIES, INC. |
K040277 |
02/05/2004 |
LIQUICHEK CARDIAC MARKER CONTROL LT |
BIO-RAD LABORATORIES, INC. |
K022041 |
06/24/2002 |
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 |
BIO-RAD LABORATORIES, INC. |
K042336 |
08/30/2004 |
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK |
BIO-RAD LABORATORIES, INC. |
K042335 |
08/30/2004 |
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 |
BIO-RAD LABORATORIES, INC. |
K042446 |
09/09/2004 |
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS |
BIO-RAD LABORATORIES, INC. |
K970126 |
01/14/1997 |
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) |
BIO-RAD LABORATORIES, INC. |
K181661 |
06/25/2018 |
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System |
Bio-Rad Laboratories, Inc. |
K130963 |
04/08/2013 |
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK |
BIO-RAD LABORATORIES, INC. |
K043108 |
11/09/2004 |
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL |
BIO-RAD LABORATORIES, INC. |
K043584 |
12/28/2004 |
LIQUICHEK BNP CONTROL |
BIO-RAD LABORATORIES, INC. |
K171664 |
06/05/2017 |
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software |
Bio-Rad Laboratories, Inc. |
K051072 |
04/26/2005 |
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM |
BIO-RAD LABORATORIES, INC. |