IDI-STREP B ASSAY

FDA 510(k)

FDA Class 1 ·Microbiology

XPERT, GENEXPERT DX SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Xpress Strep A

FDA 510(k)

FDA Class 2 ·Microbiology

LIAT STREP A ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Solana Strep Complete Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Solana GAS Assay, Solana instrument

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Xpress Strep A

FDA 510(k)

FDA Class 2 ·Microbiology

Accula Strep A Test

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

AMPLIVUE GAS ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

ALERE I STREP A

FDA 510(k)

FDA Class 2 ·Microbiology

LYRA DIRECT STREP ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

GenePOC Strep A

FDA 510(k)

FDA Class 2 ·Microbiology

HERPTRAN CONCENTRATE

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6

FDA 510(k)

FDA Class 2 ·Microbiology

IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS

FDA 510(k)

FDA Class 2 ·Microbiology

ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology

POCKIT HSV 2 RAPID TEST

FDA 510(k)

FDA Class 2 ·Microbiology