ANTI-DSDNA ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

ANTINUCLEAR ANTIBODY IMMUNOLOGICAL

FDA 510(k)

FDA Class 2 ·Immunology

PRO HMPV+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

QUIDEL MOLECULAR RSV + HMPV ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO

FDA 510(k)

FDA Class 2 ·Immunology

ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96

FDA 510(k)

FDA Class 2 ·Immunology

ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

iSurg

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME CMV

GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01

FDA 510(k)

FDA Class 2 ·Immunology

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV TEST VERSION 2.0

SELISA ANTI-N DNA ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)

FDA 510(k)

FDA Class 2 ·Immunology

UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE

FDA 510(k)

FDA Class 2 ·Immunology

ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology