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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·Elecsys Anti-HBc II / Elecsys Anti-HBc IgM

QUANTA LITE CCP3.1 IGG/IGA ELISA

FDA 510(k)
FDA Class 2 ·Immunology

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

FDA 510(k)
FDA Class 2 ·Immunology

UCEZ - STERILE LENS FOG REDUCTION DEVICE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FOG CONTROL, LENS FOG REDUCTION DEVICE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DEFOGGING AND CLEANING SOLUTION- FLO-X

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

RHIGENE MESACUP-2 TEST RNP, MODEL M7741

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

LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED

FDA 510(k)
FDA Class 2 ·Microbiology

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

EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)

FDA 510(k)
FDA Class 2 ·Immunology

SYNELISA SM ABS/RNP-SM ABS

FDA 510(k)
FDA Class 2 ·Immunology

CCPOINT

FDA 510(k)
FDA Class 2 ·Immunology

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200

FDA 510(k)
FDA Class 2 ·Immunology

THERATEST EL-ANA PROFILES

FDA 510(k)
FDA Class 2 ·Immunology