System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT

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

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

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

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·SPOT-LIGHT HER2 CISH KIT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Bioprosthesis, Models 995, 995CS and 995MS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Bioprosthesis, Models 305 and 310

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II Bioprosthesis, Models T505 and T510

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC HALL PROSTHETIC HEART VALVE, AORTIC VALVED CONDUIT, AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK 1 STANDARD BIOPROSTHETIC VALVE

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·Inform HER2 Dual ISH DNA Probe Cocktail

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 HPV DNA TEST

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·VENTANA HER2 Dual ISH DNA Probe Cocktail

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL