ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST

FDA 510(k)

FDA Class 2 ·Microbiology

MONITORX LASERX THEOPHYLLINE REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SODIUM AND POTASSIUM BY ION SELECTIVE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

INFLUENZA A/B RAPID TEST, CAT NO 2158 663

FDA 510(k)

FDA Class 2 ·Microbiology

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P

FDA 510(k)

FDA Class 2 ·Hematology

ENZYMATIC CO2 REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ETHANOL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DURAZYME(R) CPK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KINETIC 610 ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV RNA QUALITATIVE ASSAY

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT ARCHITECT ANTI-HCV

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS HCV TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Alinity m HCV

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)