MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

MACRA LP(A) ENZYME IMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

ACCUTEX CRP LATEX TEST

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896

FDA 510(k)

FDA Class 2 ·Immunology

RAPET RF

FDA 510(k)

FDA Class 2 ·Immunology

VENTREX 125I ANTI-IGE ALLERGY ISOTOPE

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA

FDA 510(k)

FDA Class 2 ·Immunology

C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANA IFA: HEP-20-10

FDA 510(k)

FDA Class 2 ·Immunology

HYTEC AUTOIMMUNE KITS (SM)

FDA 510(k)

FDA Class 2 ·Immunology

IFA ANTI-NDNA

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMATELL

FDA 510(k)

FDA Class 2 ·Immunology

VIDAS AFP ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

HUMAN IGA2 KIT FOR USE ON THE SPAPLUS

FDA 510(k)

FDA Class 2 ·Immunology

Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria

FDA 510(k)

FDA Class 2 ·Immunology

C4 MININEPH ANTISERUM

FDA 510(k)

FDA Class 2 ·Immunology

MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H

FDA 510(k)

FDA Class 2 ·Immunology