Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anbti-HCV Immunoassay

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS HCV TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HCV TEST/COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS CMV

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS HCV TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBRA TAQMAN CMV TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0

SleepImage System

FDA 510(k)

FDA Class 2 ·Anesthesiology

MBA Biotech Implant System

FDA 510(k)

FDA Class 2 ·Dental

GOLNIT Non-Absorbable PTFE Surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cortex Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TOTAL LUNG EXERCISER (TLE)

FDA 510(k)

FDA Class 2 ·Anesthesiology

MULTI-MODALITY IMAGE FUSION

FDA 510(k)

FDA Class 2 ·Radiology