Genabio Diagnostics Inc.

Address:19B Crosby Dr. Ste 220,Bedford,MA,01730,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Coronavirus Antigen Detection Test System. (QKP) (4)

Premarket Exempt

Yes

Clear

Genabio COVID-19 Rapid Self-Test Kit - 00196852195008 Catalog Number :

Device Class :

Duns Number: 118586095

Premarket Exempt : Yes

Product Code : QKP

Prescription Use : No

Device Count : 25

Genabio COVID-19 Rapid Self-Test Kit - 00196852254316 Catalog Number :

Device Class :

Duns Number: 118586095

Premarket Exempt : Yes

Product Code : QKP

Prescription Use : No

Device Count : 1

Genabio COVID-19 Rapid Self-Test Kit - 00196852928675 Catalog Number :

Device Class :

Duns Number: 118586095

Premarket Exempt : Yes

Product Code : QKP

Prescription Use : No

Device Count : 5

Genabio COVID-19 Rapid Self-Test Kit - 00196852953004 Catalog Number :

Device Class :

Duns Number: 118586095

Premarket Exempt : Yes

Product Code : QKP

Prescription Use : No

Device Count : 2

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