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) (3)

Premarket Exempt

Yes No

Clear

GeneXpert Dx System - 07332940004156 Catalog Number : 900-0427

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 - 07332940004163 Catalog Number : 900-0426

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 - 07332940004170 Catalog Number : 900-0424

Device Description : Additional catalog number: 900-0424R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940004194 Catalog Number : 900-0423

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 - 07332940004309 Catalog Number : 900-0542

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 Infinity-48s System - 07332940004316 Catalog Number : 900-0540

Device Description : Additional catalog numbers: 900-0540L, 900-0540R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Infinity-48s System - 07332940004323 Catalog Number : 900-0539

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Infinity-48s System - 07332940004330 Catalog Number : 900-0538

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Infinity-48s System - 07332940004347 Catalog Number : 900-0537

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Infinity-48s System - 07332940004354 Catalog Number : 900-0536

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

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