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

FDA 510(k)

FDA Class 2 ·Immunology

BD MAX™ CPO

FDA UDI

BECTON, DICKINSON AND COMPANY·00382904452629·Kit BD MAX CPO

Elite InGenius

FDA registration

ELITechGroup S.p.A.·2 products·🇮🇹 Italy

ELITe MGB HSV 1&2 Assay

FDA registration

ELITechGroup MDX LLC.·2 products·🇺🇸 United States

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE II HIGH-RISK HPV DNA TEST

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·HYBRID CAPTURE(TM) SYSTEM VIRATYPE(R) PLUS HPV DNA

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·QIAGEN THERASCREEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·QIAGEN THERASCREEN KRAS RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR Mutation Test v2

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP 2000 SYSTEM

iSurg

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HEp-2000® Fluorescent ANA-Ro Test System

FDA UDI

IMMUNO CONCEPTS INC·M74920100101·ANA Sample Diluent 10 x 100mls

HEp-2000® Fluorescent ANA-Ro Test System

FDA UDI

IMMUNO CONCEPTS INC·M7492010011·ANA Sample Diluent 1 x 100mls

HEp-2000® Fluorescent ANA-Ro Test System

FDA UDI

IMMUNO CONCEPTS INC·M7490002001·Serum Diluent 4 x 100ml

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval

FDA Class 3 ·TOP2A FISH PHARMDX KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT