System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·NMP22 ELISA TEST KIT

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·NMP22 BLADDERCHEK TEST KIT

BINAXNOX STAPHYLOCOCCUS AUREUS TEST

FDA 510(k)

FDA Class 1 ·Microbiology

MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

BINAS LUTEINIZING HORMONE IRMA TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST

FDA 510(k)

FDA Class 1 ·Microbiology

BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065

FDA 510(k)

FDA Class 1 ·Microbiology

BINAX EQUATE STREP B

FDA 510(k)

FDA Class 1 ·Microbiology

BINAXNOW G6PD TEST

FDA 510(k)

FDA Class 2 ·Hematology

BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK

FDA 510(k)

FDA Class 1 ·Microbiology

BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK

FDA 510(k)

FDA Class 2 ·Microbiology

EQUATE(TM) AQR APO AL/B DUO CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK

FDA 510(k)

FDA Class 2 ·Microbiology

BINAX EQUATE GLYCOHEMOGLOBIN

FDA 510(k)

FDA Class 2 ·Hematology

BINAXNOW INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

BINAX IRMA TOTAL BETA-HCG TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLEARVIEW EXACT PBP2A TEST, MODEL 891-000

FDA 510(k)

FDA Class 2 ·Microbiology

BINAX STREP A TEST

FDA 510(k)

FDA Class 1 ·Microbiology