CEPHEID

Address:904 CARIBBEAN DRIVE,Sunnyvale,CA,94089,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

Real Time Nucleic Acid Amplification System (OOI) (10)

Premarket Exempt

Yes No

Clear

GeneXpert Infinity-80 System - 07332940003838 Catalog Number : 900-0495

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Certified Pre-Owned GeneXpert Dx System - 07332940003852 Catalog Number : 900-0485R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Certified Pre-Owned GeneXpert Dx System - 07332940003890 Catalog Number : 900-0513R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Certified Pre-Owned GeneXpert Dx System - 07332940003913 Catalog Number : 900-0512R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Certified Pre-Owned GeneXpert Dx System - 07332940003920 Catalog Number : 900-0511R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Certified Pre-Owned GeneXpert Dx System - 07332940003937 Catalog Number : 900-0510R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Certified Pre-Owned GeneXpert Dx System - 07332940003951 Catalog Number : 900-0505R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Infinity-80 System - 07332940003968 Catalog Number : 900-0503

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Infinity-80 System - 07332940003975 Catalog Number : 900-0502

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Infinity-80 System - 07332940003982 Catalog Number : 900-0501

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

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