System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KENTROX RV LEAD SYSTEMS

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KAINOX RV-S/ KAINOX VCS ICD LEADS

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R) R CEA IMMUNORADIOMETRIC ASSAY

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18

Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern

FDA 510(k)

FDA Class 2 ·Immunology

ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01

FDA 510(k)

FDA Class 2 ·Immunology

AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10

FDA 510(k)

FDA Class 2 ·Immunology

THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-NATIVE DNA ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

DISTAT ANTI-DSDNA KIT

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls

FDA 510(k)

FDA Class 2 ·Immunology