TERRAGENE S.A.

TERRAGENE S.A.

Address:Ruta Nacional No. 9, Km 280,,Alvear Santa Fe,AR

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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

Indicator, Biological Sterilization Process (FRC) (2)

Premarket Exempt

No

Clear

Bionova® - 07798164679769 Catalog Number :

Device Description : Steam Test Pack PCD Kit (25 test packs and 25 control BIs)

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 1

Bionova® - 07798164679813 Catalog Number :

Device Description : Self-contained Biological Indicator for monitoring steam sterilization processes

Device Class : 2

Duns Number: 970856911

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 25

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