THE KEYMED HI-LIGHT 250 LIGHT SOURCE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BACKSTOP AND BACKSTOP INJECTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS

FDA 510(k)

FDA Class 2 ·Immunology

DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

APTOS Threads – Polypropylene Surgical Sutures

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS

FDA 510(k)

FDA Class 2 ·Immunology

Tristel OPH

FDA 510(k)

FDA Class 2 ·General Hospital

Tristel Duo ULT

FDA 510(k)

FDA Class 2 ·General Hospital

Oxiplex®

FDA 510(k)

FDA Class 2 ·Orthopedic

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 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 ·VERSANT 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 ·VERSANT HCV RNA QUALITATIVE ASSAY/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 ·VERSANT HCV RNA QUALITATIVE ASSAY/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 ·VERSANT & APTIMA HCV RNA QUALITATIVE ASSAY