QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO

FDA 510(k)

FDA Class 2 ·Immunology

ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250

FDA 510(k)

FDA Class 2 ·Immunology

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT ARCHITECT TOTAL PSA

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT AXSYM TOTAL PSA ASSAY

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT IMX TOTAL PSA

ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

FDA 510(k)

FDA Class 2 ·Immunology

ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

ELISA-DOXA SM/RNP

FDA 510(k)

FDA Class 2 ·Immunology

ANA/LITE-HEP-2 TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOSCAN RA ANTI-CCP TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE ENA 5 ELISA KIT

FDA 510(k)

FDA Class 2 ·Immunology

IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS

FDA 510(k)

FDA Class 2 ·Immunology

DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

HEMAGEN ANTI CARDIOLIPIN SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

SELISA ANTI-N DNA ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

CalprestNG, EasyCal

FDA 510(k)

FDA Class 2 ·Immunology