Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·THE NORMALINE KIT

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·THE NORMALINE KIT

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Abbott RealTime HCV GT II

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Abbott RealTime CMV

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

FDA Pre-Market Approval

FDA Class 2 ·RealTime HCV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Cobas CMV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·artus CMV RGQ MDx Kit and artus CMV QS_RGQ MDx Kit

BONE-TEMNO/STERNUM-TEMNO

FDA 510(k)

FDA Class 2 ·Unknown

CEP 8 SPECTRUMORANGE DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CONCEIVEX CONCEPTION KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CONCEIVEX LATEX-FREE SEMEN COLLECTOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FOCUS TOUCH CONCEPTION SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ANEUVYSION

FDA 510(k)

FDA Class 2 ·Immunology

STERILE SURGICAL DRAPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)

FDA 510(k)

FDA Class 2 ·Unknown