Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·GELFOAM ABSORBABLE GELATIN SPONGE

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix Drug Coated Balloon

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·Dimension Vista FPSA Flex reagent cartridge (K6452)

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·Dimension FPSA Flex Reagent Cartridge

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·Dimension FPSA Flex reagent cartridge (RF451)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·BioFreedom Drug Coated Coronary Stent System

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval

FDA Class 3 ·RIANEN 3H

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval

FDA Class 3 ·RIANEN I125

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·Dimension Vista TPSA Flex reagent cartridge

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CATRIDGE