FTA-ABS TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·AL-47 SOFT CONTACT LENS

FTA-ABS BIOPAK

FDA 510(k)

FDA Class 2 ·Microbiology

FTA-ABS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

LAB-TEK FTA-ABS KIT

FDA 510(k)

FDA Class 2 ·Microbiology

POLYCHACO FIA-ABS TEST FOR SYPHILIS

FDA 510(k)

FDA Class 2 ·Microbiology

QUICKVUE INFLUENZA A+B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

OSOM INFLUENZA A&B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

CLEARVIEW EXACT II INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

FDA 510(k)

FDA Class 2 ·Microbiology

BD DIRECTIGEN FLU A+B

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

QUICKVUE INFLUENZA A + B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

RAMP INFLUENZA A/B ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

BD DIRECTIGEN EZ FLU A + B

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO: RAMP INFLUENZA A/B ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit

FDA 510(k)

FDA Class 2 ·Microbiology

ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST

FDA 510(k)

FDA Class 2 ·Microbiology

AB FLU OIA

FDA 510(k)

FDA Class 2 ·Microbiology