IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2

FDA 510(k)

FDA Class 2 ·Immunology

HY-TEC TOTAL IGE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA

FDA 510(k)

FDA Class 2 ·Immunology

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System

FDA 510(k)

FDA Class 2 ·Microbiology

TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE H-TTG SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

AXIS-SHIELD ANTI-CCP

FDA 510(k)

FDA Class 2 ·Immunology

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

LOMEFLOXACIN, 10 MCG, SENSI DISC

FDA 510(k)

FDA Class 2 ·Microbiology

PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology

HardyDisk AST Lefamulin 20µg (LMU20)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24

FDA 510(k)

FDA Class 2 ·Microbiology

HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

TIA-IGA REAGENT & CALIBRATOR SETS

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT(TM) ANTI-DSNA

FDA 510(k)

FDA Class 2 ·Immunology

B-HCG-RIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys AFP

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology