Address:4242 U.S. Hwy. 1,Monmouth Jct,NJ,08852,US
Device Description : BioSign Flu Control Kit (5 Postive/ 5 Negative)
Device Class :
Duns Number: 362917692
Premarket Exempt : Yes
Prescription Use : No
Device Description : Status Flu A+B; 25 Test Kit
Device Class : 1
Duns Number: 362917692
Premarket Exempt : No
Prescription Use : No
Device Description : Status DS™® TCA card; 35 Test kit
Device Class : 2
Duns Number: 362917692
Premarket Exempt : No
Prescription Use : No
Device Description : Status DS Control Set (Neg&Pos 2.5 ml)
Device Class :
Duns Number: 362917692
Premarket Exempt : Yes
Prescription Use : No
Device Description : Status™ COVID-19/Flu A&B Antigen test kit, 25 tests
Device Class : 2
Duns Number: 362917692
Premarket Exempt : No
Prescription Use : Yes
Device Description : Status™ H. pylori card; 10 Test kit
Device Class : 1
Duns Number: 362917692
Premarket Exempt : No
Prescription Use : No
Device Description : Status™ H. pylori card; 25 Test kit
Device Class : 1
Duns Number: 362917692
Premarket Exempt : No
Prescription Use : No
Device Description : PBM Cardiac Marker Control Set (2 x 1 mL)
Device Class :
Duns Number: 362917692
Premarket Exempt : Yes
Prescription Use : No