GenePOC™ Strep A

FDA UDI

GenePoc Inc·00628055344087·The GenePOC Strep A assay, performed on the rev...

Alere i Strep A 2

FDA UDI

Alere Scarborough, Inc.·10811877010040·A rapid, automated, molecular test for the qual...

Alere™ i Strep A

FDA UDI

Alere Scarborough, Inc.·10811877010859·A rapid, automated, molecular test for the qual...

Alere™ i Strep A Control Swab Kit

FDA UDI

Alere Scarborough, Inc.·10811877010866·Control Swabs intended for use only with the Al...

Revogene® Strep A

FDA UDI

Meridian Bioscience Canada Inc·00628055344179·The Revogene® Strep A assay, performed on the R...

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

Respiratory virus panel nucleic acid assay system

FDA registration

ENERCON TECHNOLOGIES·4 products·🇺🇸 United States

SPOTFIRE R/ST Panel Mini

FDA registration

BioFire Diagnostics, LLC·5 products·🇺🇸 United States