K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Immunology

EL-RF TEST SYSTEM: EL-RF-IGM KIT

FDA 510(k)

FDA Class 2 ·Immunology

MARSH ELDER ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

ANA/LITE-RL TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

FDA 510(k)

FDA Class 2 ·Immunology

TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H

FDA 510(k)

FDA Class 2 ·Immunology

ENZYMATIC ACETAMINOPHEN ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

IBD-QUIK CHEK

FDA 510(k)

FDA Class 1 ·Immunology

MAST CLA ALLERGY SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOCARD MONO

FDA 510(k)

FDA Class 2 ·Immunology

Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Immunology

FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit

FDA 510(k)

FDA Class 2 ·Immunology

NA LATEX MYOGLOBIN TEST

FDA 510(k)

FDA Class 2 ·Immunology

HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT

FDA 510(k)

FDA Class 2 ·Immunology

Tina-quant Lipoprotein(a) Gen.2 Molarity

FDA 510(k)

FDA Class 2 ·Immunology

VENTANNA ANTI-CD3 PRIMARY ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

BÜHLMANN fCAL® turbo and CALEX® Cap

FDA 510(k)

FDA Class 2 ·Immunology

ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT

FDA 510(k)

FDA Class 2 ·Immunology

IL TEST IMMUNOGLOBULIN M (IGM)

FDA 510(k)

FDA Class 2 ·Immunology