WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO

FDA 510(k)

FDA Class 2 ·Immunology

NOVA LITE TM THYROID

FDA 510(k)

FDA Class 2 ·Immunology

HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)

FDA 510(k)

FDA Class 2 ·Immunology

DU PONT DIMENSION C-REACTIVE PROTEIN METHOD

FDA 510(k)

FDA Class 2 ·Immunology

TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-DNA MICROASSAY

FDA 510(k)

FDA Class 2 ·Immunology

PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

BINDING SITE IGG SUBLCASS OLYMPUS KITS

FDA 510(k)

FDA Class 2 ·Immunology

WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

VENTANNA ANTI-DESMIN PRIMARY ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6

FDA 510(k)

FDA Class 2 ·Immunology

LANCER L-INA ANTI-C3

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer

FDA 510(k)

FDA Class 2 ·Immunology

SERAQUEST ANTI-SM/RNP

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST

FDA 510(k)

FDA Class 2 ·Immunology

FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER

FDA 510(k)

FDA Class 2 ·Immunology