Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Cap, Cervical

FDA classification

FDA Class 2 ·Cap, Cervical

Kit, Conception-Assist, Home Use

FDA classification

FDA Class 2 ·Kit, Conception-Assist, Home Use

Cap, Device Disinfectant

FDA classification

FDA Class 2 ·Cap, Device Disinfectant

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

FDA classification

FDA Class 2 ·Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

Hemodialysis Catheter Luer End Cap

FDA classification

FDA Class 2 ·Hemodialysis Catheter Luer End Cap

Procalcitonin Assay

FDA classification

FDA Class 2 ·Procalcitonin Assay

In Situ Polymerizing Peripheral Nerve Cap

FDA classification

FDA Class 2 ·In Situ Polymerizing Peripheral Nerve Cap

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS

Lens, Contact (Orthokeratology)

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES

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

FDA Pre-Market Approval

FDA Class 2 ·Aptima HCV Quant Dx Assay

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

FDA Pre-Market Approval

FDA Class 2 ·APTIMA HCV RNA QUALITATIVE ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·Aptima HCV RNA Qualitative Assay

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

FDA Pre-Market Approval

FDA Class 2 ·APTIMA HCV Quant Dx Assay

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOF!PRO-CLEAN CONTACT LENS CLEANER