Company ยท US
Bio-Rad Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2019. Name variants (Inc, Corp, punctuation) are merged.
128510(k) clearances (0 in 12 months)
91recalls (0 in 12 months)
75recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | 36 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 27 |
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 11 |
| LKJ | Antinuclear Antibody, Antigen, Control | 11 |
| DIF | Drug Mixture Control Materials | 5 |
| GKA | Abnormal Hemoglobin Quantitation | 5 |
| LSE | Epstein-Barr Virus, Other | 5 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 4 |
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | 4 |
| LOM | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 4 |
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | 4 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 3 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 3 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 3 |
| JPD | Hemoglobin A2 Quantitation | 3 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 3 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 3 |
| MID | System, Test, Anticardiolipin Immunological | 3 |
| PDJ | Hemoglobin A1c Test System | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 12, 2019 | K183446 | BioPlex 2200 Lyme Total Bio-Rad Laboratories | LSR |
| Feb 13, 2019 | K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System Bio-Rad Laboratories, Inc. | OYX |
| Jun 22, 2018 | K180577 | BioPlex 2200 25-OH Vitamin D Kit Bio-Rad Laboratories | MRG |
| Sep 13, 2017 | K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software Bio-Rad Laboratories, Inc. | GKA |
| May 19, 2017 | K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set Bio-Rad Laboratories | PUQ |
| May 11, 2017 | K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR C Bio-Rad Laboratories | LIP |
| Jan 10, 2017 | K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Bio-Rad Laboratories | JJY |
| Oct 14, 2016 | K161687 | D-10 Hemoglobin A1c Program Bio-Rad Laboratories, Inc. | PDJ |
| May 10, 2016 | K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak Bio-Rad Laboratories | PMN |
| Mar 28, 2016 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Ampl Bio-Rad Laboratories | PMN |
| Dec 11, 2015 | K150300 | Liquichek Cardiac Markers Plus Control LT Bio-Rad Laboratories | JJY |
| Dec 9, 2015 | K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack Bio-Rad Laboratories, Inc. | PDJ |
| Mar 24, 2015 | K142448 | VARIANT II TURBO HbA1c Kit - 2.0 Bio-Rad Laboratories, Inc. | PDJ |
| Mar 13, 2015 | K143379 | Liquichek Maternal Serum II Control Bio-Rad Laboratories | JJY |
| Jan 9, 2015 | 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 Bio-Rad Laboratories | MRG |
| Jun 25, 2014 | K140801 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM Bio-Rad Laboratories, Inc. | LCP |
| Jun 23, 2014 | K141073 | LIQUICHEK TUMOR MARKER CONTROL Bio-Rad Laboratories | JJY |
| May 6, 2014 | K140916 | LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK Bio-Rad Laboratories | JJY |
| Apr 25, 2014 | K140764 | LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK Bio-Rad Laboratories | JJY |
| Apr 24, 2014 | K134013 | LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO Bio-Rad Laboratories | JJY |
| Jan 22, 2014 | K133960 | LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL Bio-Rad Laboratories | JJY |
| Oct 25, 2013 | K132227 | LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY Bio-Rad Laboratories | JJY |
| Oct 21, 2013 | K130528 | BIOPLEX 2200 APLS IGM Bio-Rad Laboratories | MID |
| Sep 19, 2013 | K130053 | 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. | MVM |
| May 6, 2013 | K130963 | LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK Bio-Rad Laboratories, Inc. | JJY |
| Apr 12, 2013 | K130761 | LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK Bio-Rad Laboratories | JJY |
| Mar 1, 2013 | K130162 | LIQUID ASSAYED MULTIQUAL PREMIUM Bio-Rad Laboratories | JJY |
| Jan 31, 2013 | K123775 | LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK Bio-Rad Laboratories | JJY |
| Jan 9, 2013 | K123798 | LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK Bio-Rad Laboratories | JJX |
| Dec 27, 2012 | K123663 | LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK Bio-Rad Laboratories | JJY |
| Nov 20, 2012 | K123198 | LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA Bio-Rad Laboratories | JJY |
| Nov 2, 2012 | K123021 | BIOPLEX 2200 EBV IGM KIT Bio-Rad Laboratories | LJN |
| Oct 17, 2012 | K122838 | LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK Bio-Rad Laboratories | JJY |
| Jul 9, 2012 | K113610 | ANA-SCREEN WITH MDSS Bio-Rad Laboratories | LKJ |
| Jun 22, 2012 | K120959 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT Bio-Rad Laboratories | MXJ |
| May 18, 2012 | K121143 | LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) Bio-Rad Laboratories | DIF |
| Mar 30, 2012 | K103834 | BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS Bio-Rad Laboratories | MID |
| Mar 27, 2012 | K120504 | LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK Bio-Rad Laboratories, Inc. | DIF |
| Mar 26, 2012 | K120572 | BIOPLEX 2200 TORC IGG Bio-Rad Laboratories, Inc. | OMI |
| Mar 14, 2012 | K120439 | BIOPLEX 2200 EBV IGG AND SYPHILIS IGG Bio-Rad Laboratories, Inc. | LIP |
| Oct 26, 2011 | K112810 | MULTI-ANALYTE DETECTION SYSTEMS Bio-Rad Laboratories | NHX |
| Aug 23, 2011 | K111072 | BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL Bio-Rad Laboratories | OPL |
| Dec 3, 2010 | K092587 | BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM Bio-Rad Laboratories | LFX |
| Aug 24, 2010 | K093954 | BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM Bio-Rad Laboratories | NHX |
| Aug 2, 2010 | K091303 | LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV Bio-Rad Laboratories | JPK |
| Mar 29, 2010 | K091616 | BIOPLEX 2200 MMRV IGG Bio-Rad Laboratories | OPL |
| Mar 12, 2010 | K093577 | LIQUICHEK OPIATE CONTROL Bio-Rad Laboratories | DIF |
| Oct 29, 2009 | K092355 | MONOLISA ANTI-HAV EIA Bio-Rad Laboratories, Inc. | LOL |
| Oct 29, 2009 | K092353 | MONOLISA ANTI-HAV IGM EIA Bio-Rad Laboratories, Inc. | LOL |
| Jul 27, 2009 | K090699 | VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 Bio-Rad Laboratories, Inc. | LCP |
Newest 50 of 128.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2025 | Bio-Rad Laboratories, Inc. Platelia Toxo IgM Catalog Number 26211
UDI Code: 03610520005552
The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplas Open, Classified |
LGD | K090847 |
| Mar 22, 2024 | Bio-Rad Laboratories Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit Open, Classified |
OYX | K181661 |
| May 10, 2023 | Bio-Rad Laboratories, Inc. BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack Open, Classified |
MID | K130528 |
| Apr 12, 2023 | Bio-Rad Laboratories, Inc. BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD Open, Classified |
NHX | K093954 K112810 |
| Apr 12, 2023 | Bio-Rad Laboratories, Inc. BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD Open, Classified |
NHX | K093954 K112810 |
| Dec 6, 2022 | Bio-Rad Laboratories, Inc. CMV IgM EIA, in vitro diagnostic. Open, Classified |
LFZ | K982485 |
| Apr 14, 2022 | Bio-Rad Laboratories, Inc. BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack Open, Classified |
LIP | None listed |
| Apr 7, 2022 | Bio-Rad Laboratories, Inc. Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000 Open, Classified |
GKA | K051072 |
| Feb 8, 2022 | Bio-Rad Laboratories, Inc. BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL Open, Classified |
LIP | K170413 |
| Feb 8, 2022 | Bio-Rad Laboratories, Inc. BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack Open, Classified |
LIP | K170413 |
| Sep 17, 2021 | Bio-Rad Laboratories, Inc. BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RP Open, Classified |
LIP | K170413 |
| Sep 17, 2021 | Bio-Rad Laboratories, Inc. BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (I Open, Classified |
LIP | K170413 |
| Apr 21, 2020 | Bio-Rad Laboratories, Inc. BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponem Open, Classified |
LIP | K170413 |
| Nov 1, 2019 | Bio-Rad Laboratories, Inc. BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101 Terminated |
LKJ | K041658 K113610 |
| Jan 10, 2019 | Bio-Rad Laboratories, Inc EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A. Open, Classified |
JJE | None listed |
| Jun 8, 2018 | Bio-Rad Laboratories, Inc MRSASelect II, IVD, REF 63758 (20 plates per package).
The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and dia Terminated |
JSO | K171061 |
| Jun 8, 2018 | Bio-Rad Laboratories, Inc MRSASelect, IVD, REF 63747, containing 20 plates per package.
The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification a Terminated |
JSO | K081212 |
| Apr 2, 2018 | Bio-Rad Laboratories Inc PR4100 Microplate Reader US, Catalog Number 45591587
Product Usage:
The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid Terminated |
JJE | None listed |
| Feb 13, 2016 | Bio-Rad Laboratories, Inc. EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic
Product Usage:
EVOLIS Microplate System is a 4 plate fully integrated microplate p Terminated |
JJE | None listed |
| Jan 27, 2016 | Bio-Rad Laboratories, Inc. D-10 Rack Loader;
Model Number 220-0600;
Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent k Terminated |
LCP | K060001 |
| Jun 25, 2015 | Bio-Rad Laboratories, Inc. The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154.
The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in Terminated |
JJX | None listed |
| May 2, 2014 | Bio-Rad Laboratories, Inc. Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses t Terminated |
JPD | K991127 |
| Mar 27, 2014 | Bio-Rad Laboratories, Inc. D-10" Hemoglobin Testing System,
Model number: 220-0220
Manufactured by:
Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Drive
Hercules, CA 94545
The D-10 Hemoglobin Testing System is a single module Terminated |
LCP | K031043 |
| Feb 10, 2014 | Bio-Rad Laboratories, Inc. D-10 Dual Program, which contains Update Kit D-10 A1c program diskette.
United States; Bio-Rad Laboratories,
Hercules, CA 94547
The Bio-Rad D-10 Hemoglobin Testing System provides an integrated meth Terminated |
LCP | K031043 |
| Oct 21, 2013 | Bio-Rad Laboratories FSE Image Upgrade Kit, Catalog # 92019C
This kit is used to install and/or upgrade software used with the EVOLIS Microplate System. Terminated |
LOM | None listed |
| May 16, 2013 | Bio-rad Laboratories, Inc. Liquichek" ToRCH Plus IgM Control - Positive
Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for t Terminated |
JJY | K040822 |
| Sep 17, 2012 | Bio-Rad Laboratories 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 hepatit Terminated |
LOM | None listed |
| Jan 11, 2012 | Bio-Rad Laboratories, Inc. VARIANT II Link Hemoglobin A1c Program Reorder Pack,
1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood.
Contents:
Elution Buffer A , 1 x 2500 mL
Elution Buffer B, 1 x 2100 Terminated |
KRZ | K070819 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests.
For the determination of Hemoglobin A1c in human whole blood.
Contents:
1. Elution Buffer A, 1 x 2500 mL Bis-Tris Phosphate Buff Terminated |
LCP | K070819 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set.
Made in United States.
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-e Terminated |
LCP | K070819 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,.
Made in United States.
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood u Terminated |
LCP | K924122 K991127 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made Terminated |
LCP | K991127 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made Terminated |
LCP | K991127 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO Hemoglobin A1c Program Buffer B,
Made in United States.
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange h Terminated |
LCP | K040872 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. 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 Terminated |
LCP | K040872 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. 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 Terminated |
LCP | K040872 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. 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 ch Terminated |
LCP | K031043 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. 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 c Terminated |
LCP | K031043 |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. 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 Terminated |
LCP | K031043 |
| Sep 6, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack.
Calibrator/Diluent Set.
IVD.
Kit components:
Elution Buffer A, 2 x 2500 mL
Elution Buffer B, 1 x 2100 mL
Wash/Diluent Solution, 1 x 2500 mL
C Terminated |
LCP | K070819 |
| Aug 22, 2011 | Bio-Rad Laboratories "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN"
The test kit contains slides and substrate.
For use as an indirect fluorescent antibody procedure for the d Terminated |
DHN | K813592 |
| Jul 27, 2011 | Bio-Rad Laboratories Inc D-10 Dual Program Reorder Pack;
contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include Elution Buffer 1 and 2; Calibrator 1 & 2.
Bio-Rad Laboratories Inc. Hercules, CA.
Product Usage:
Short Prog Terminated |
LCP | K041444 |
| May 19, 2011 | Bio-Rad Laboratories Software CD is labeled in part:
"BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***"
The EVOLIS Assay Protocol Files (APF) Software contains assay-specific Terminated |
LFX | K092353 K961053 |
| Apr 27, 2011 | Bio-Rad Laboratories BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200.
Product is labeled in part: "BIO-RAD***BioPlex 2200 EBV IgG Calibrator Set***7 x 0.5 mL***A Calibrator set for the BioPlex 2200 EBV IgG Reagen Terminated |
LSE | K062211 |
| Apr 14, 2011 | Bio-Rad Laboratories Inc VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intende Terminated |
GKA | None listed |
| Apr 11, 2011 | Bio-Rad Laboratories Inc Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. Catalog Numbers: 270-2417 and 270-2415; Distributed and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, Terminated |
LCP | None listed |
| Apr 6, 2011 | Bio-Rad Laboratories Inc Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard Cartridge Insert***UNITED STATES, Bio-Rad Labo Terminated |
LCP | K063400 |
| Mar 29, 2011 | Bio-Rad Laboratories Inc The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA
The VARIANT Sickle Cell Short Program is designed as a qualitative screen f Terminated |
GKA | K924813 |
| Mar 18, 2011 | Bio-Rad Laboratories, Inc. PhD System EIA/IFA Software; Model/Catalog Number: 426-0246;
The Bio-Rad PhD System is an EIA and IFA processing system that consists of a PhD fluid handling station(s) linked to a network computer Terminated |
JQW | None listed |
| Mar 14, 2011 | Bio-Rad Laboratories Inc Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 576 Tests,
Catalog No. 576DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA
The Bio-Rad Autoimmune EIA Anti-dsDNA Test Terminated |
LRM | K960091 |
Newest 50 of 91.