ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

FDA 510(k)

FDA Class 2 ·Immunology

MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE

FDA 510(k)

FDA Class 2 ·Hematology

MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910)

FDA 510(k)

FDA Class 2 ·Hematology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV REAGENT KITS, ARCHITECT ANTI-HCV CALIBRATORS, AND ARCHITECT ANTI-HCV CONTROLS

IMMUNOSCAN RA ANTI-CCP TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

REAADS IGM ANTI-B2GP1 TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-HUMAN LEU-2A (CD8) PE

FDA 510(k)

FDA Class 2 ·Hematology

ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-HUMAN LEU-3A (CD4) FITC

FDA 510(k)

FDA Class 2 ·Hematology

FITC GOAT ANTI-HUMAN KAPPA AFFINITY

FDA 510(k)

FDA Class 2 ·Immunology

ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-JO-1 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-GLIADIN IGG ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ORGENTEC ANTI-MPO (P-ANCA) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA

FDA 510(k)

FDA Class 2 ·Immunology

Anti-Borrelia burgdorferi US Westernblot (IgG)

FDA 510(k)

FDA Class 2 ·Microbiology

EXTENSION SET WITH ANTI-SIPHON VALVE

FDA 510(k)

FDA Class 2 ·General Hospital