Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV

SERADYN QMS TOPIRAMATE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

QUANTA LITE RIBOSOME P ELISA

FDA 510(k)

FDA Class 2 ·Immunology

EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-PLA2R ELISA (IGG)

FDA 510(k)

FDA Class 2 ·Microbiology

QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EUROIMMUN ANTI-PLA2R IFA

FDA 510(k)

FDA Class 2 ·Microbiology

RIBOSOMAL P EIA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

EliA Rib-P

FDA 510(k)

FDA Class 2 ·Immunology

ARK Lacosamide Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY

ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI

FDA 510(k)

FDA Class 2 ·Immunology

MEDLINE ANTI-EMBOLISM STOCKING

FDA 510(k)

FDA Class 2 ·General Hospital

HEMAGEN ANTI CARDIOLIPIN SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-JO-1 MICROASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-HUMAN LAMBDA SERUM

FDA 510(k)

FDA Class 2 ·Immunology

MEDLINE ANTI-REFLUX VALVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology