Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM

Stent, Renal

FDA classification

FDA Class 3 ·Stent, Renal

Stent, Iliac

FDA classification

FDA Class 3 ·Stent, Iliac

Stent, Carotid

FDA classification

FDA Class 3 ·Stent, Carotid

Organ Care System (Ocs) Heart System

FDA classification

FDA Class 3 ·Organ Care System (Ocs) Heart System

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS

Pulmonary Stent

FDA classification

FDA Class 3 ·Pulmonary Stent

Stent, Superficial Femoral Artery

FDA classification

FDA Class 3 ·Stent, Superficial Femoral Artery

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV ASSAY

Antibody To Htlv-1, Elisa

FDA classification

FDA Class 3 ·Antibody To Htlv-1, Elisa

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA classification

FDA Class 3 ·Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

Absorbable Coronary Drug-Eluting Stent

FDA classification

FDA Class 3 ·Absorbable Coronary Drug-Eluting Stent

Transilluminator (Diaphanoscope)

FDA classification

FDA Class 3 ·Transilluminator (Diaphanoscope)

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY HER-2/NEU (CLONE CD11) PRIMARY ANTIBODY

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV 16/18