ABIOGENIX INC

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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

Applicator, Absorbent Tipped, Sterile (KXG) (3) Applicator, Absorbent Tipped, Non-Sterile (KXF) (2)

Premarket Exempt

Yes

Clear

Abiogenix FAST Spiral Nasopharyngeal Swab - 00860003936801 Catalog Number : NP-SWAB-080-NS-1

Device Description : FAST Spiral Nasopharyngeal Swab, 80 mm Break Point, Packaged and Sterilized, Single

Device Class : 1

Duns Number: 801937041

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

Abiogenix FAST Spiral Nasopharyngeal Swab - 00860003936818 Catalog Number : NP-SWAB-080-1000-S

Device Description : FAST Spiral Nasopharyngeal Swab, 80 mm Break Point, Packaged and Sterilized, Case/1000

Device Class : 1

Duns Number: 801937041

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

Abiogenix FAST Spiral Nasopharyngeal Swab - 00860003936825 Catalog Number : NP-SWAB-080-100-NS

Device Description : FAST Spiral Nasopharyngeal Swab, 80 mm Break Point, Packaged and Non-Sterile, Box/100

Device Class : 1

Duns Number: 801937041

Premarket Exempt : Yes

Product Code : KXF

Prescription Use : Yes

Device Count : 1

Abiogenix FAST Spiral Nasopharyngeal Swab - 00860003936832 Catalog Number : NP-SWAB-080-1000-NS

Device Description : FAST Spiral Nasopharyngeal Swab, 80 mm Break Point, Packaged and Non-Sterile, Case/1000

Device Class : 1

Duns Number: 801937041

Premarket Exempt : Yes

Product Code : KXF

Prescription Use : Yes

Device Count : 1

Abiogenix FAST Spiral Nasopharyngeal Swab - 00860003936849 Catalog Number : NP-SWAB-080-100-S

Device Description : FAST Spiral Nasopharyngeal Swab, 80 mm Break Point, Packaged and Sterilized, Box/100

Device Class : 1

Duns Number: 801937041

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

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