GILFORD IMMUNOGLOBULIN A REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

ETEST VANCOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

Lumpipulse G CA19-9-N

FDA 510(k)

FDA Class 2 ·Immunology

GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC

FDA 510(k)

FDA Class 2 ·Immunology

DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO

FDA 510(k)

FDA Class 2 ·Immunology

MUELLER HINTON SENSITIVITY PLATE

FDA 510(k)

FDA Class 2 ·Microbiology

AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK

FDA 510(k)

FDA Class 2 ·Immunology

LAMBDA SERUM (FREE) ANTI-HUMAN

FDA 510(k)

FDA Class 2 ·Immunology

ACA IMMUNOGLOBULIN G CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

FDA 510(k)

FDA Class 2 ·Microbiology

ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

Elecsys CA 15-3 II

FDA 510(k)

FDA Class 2 ·Immunology

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

KALLESTAD FLORESCENT ANA/AMA/ASMA TEST

FDA 510(k)

FDA Class 2 ·Immunology

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

HERPES

FDA 510(k)

FDA Class 2 ·Microbiology

QUANTA LITE LKM-1 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

Alinity m HSV 1 & 2 / VZV

FDA 510(k)

FDA Class 2 ·Microbiology

QUALITROL RF CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology