GENASIS SCANVIEW SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

NOVA LITE(TM) AUTOANTIBODY CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ANTISERUM TO RABBIT IGG H & L CHAIN

FDA 510(k)

FDA Class 2 ·Immunology

A1AT Genotyping Test

FDA 510(k)

FDA Class 2 ·Immunology

FLIPSCREEN QAT

FDA 510(k)

FDA Class 2 ·Immunology

EQUATE(TM) AQR APO AL/B DUO CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

JUNE GRASS ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

QUALITROL CRP CONTROL SET

FDA 510(k)

FDA Class 2 ·Immunology

VENTRE/SPEC IGE CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD

FDA 510(k)

FDA Class 2 ·Immunology

EliA SmDP Immunoassay

FDA 510(k)

FDA Class 2 ·Immunology

MULTI-ANALYTE DETECTION SYSTEMS

FDA 510(k)

FDA Class 2 ·Immunology

ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed

FDA 510(k)

FDA Class 2 ·Immunology

FLUOROSKAN

FDA 510(k)

FDA Class 1 ·Immunology

AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

SS-A(RO) & SS-B(LA) ANTIBODY ASSAY

FDA 510(k)

FDA Class 2 ·Immunology