Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME CMV

ELITe MGB Software

FDA registration

ELITechGroup MDX LLC.·3 products·🇺🇸 United States

cobas® MRSA/SA Test

FDA UDI

Roche Molecular Systems, Inc.·00875197004410·

cobas® MRSA/SA Test

FDA UDI

Roche Molecular Systems, Inc.·00875197004427·

LightCycler® Advanced Lysis

FDA UDI

Roche Molecular Systems, Inc.·00875197002997·

BD MAX™ MRSA XT

FDA UDI

BECTON, DICKINSON AND COMPANY·00382904434618·Kit BD Max MRSA XT

BD MAX™ StaphSR

FDA UDI

BECTON, DICKINSON AND COMPANY·00382904434199·Kit BD MAX StaphSR

cobas® MRSA/SA Controls and Cofactor Kit

FDA UDI

Roche Molecular Systems, Inc.·00875197004441·

LightCycler® MRSA Advanced Test

FDA UDI

Roche Molecular Systems, Inc.·00875197002973·

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

Inqwire Diagnostic Guide Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

NHancer Rx

FDA 510(k)

FDA Class 2 ·Cardiovascular

CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)

FDA 510(k)

FDA Class 1 ·Dental

Advocate PTA Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

SELISA ANTI-N DNA ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology