CEPHEID

Address:44509 Pacific Commons Boulevard,Fremont,CA,94538,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) Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (NJR) (6)

Premarket Exempt

Yes No

Clear

GeneXpert Infinity-80 System - 07332940003999 Catalog Number : 900-0500

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Infinity-80 System - 07332940004002 Catalog Number : 900-0499

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Infinity-80 System - 07332940004019 Catalog Number : 900-0498

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940004033 Catalog Number : 900-0400

Device Description : XPERT, GENEXPERT DX SYSTEM

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI, NJR

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940004040 Catalog Number : 900-0393

Device Description : XPERT, GENEXPERT DX SYSTEM

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940004057 Catalog Number : 900-0392

Device Description : XPERT, GENEXPERT DX SYSTEM

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI, NJR

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940004071 Catalog Number : 900-0381

Device Description : XPERT, GENEXPERT DX SYSTEM

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI, NJR

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940004125 Catalog Number : 900-0433

Device Description : XPERT, GENEXPERT DX SYSTEM

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI, NJR

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940004132 Catalog Number : 900-0429

Device Description : XPERT, GENEXPERT DX SYSTEM

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI, NJR

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940004149 Catalog Number : 900-0428

Device Description : XPERT, GENEXPERT DX SYSTEM

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI, NJR

Prescription Use : No

Device Count : 1

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