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) (7) Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (NJR) (4) Device, Specimen Collection (LIO) (2) Culture Media, Non-Propagating Transport (JSM) (1)

Premarket Exempt

No Yes

Clear

Xpert Vaginal/Endocervical Specimen Collection Kit - 07332940002558 Catalog Number : SWAB/A-50

Device Description : Xpert Vaginal/Endocervical Specimen Collection Kit; 50 pack

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : LIO

Prescription Use : Yes

Device Count : 1

Xpert Nasopharyngeal Sample Collection Kit - 07332940002565 Catalog Number : SWAB/B-100

Device Description : Xpert Nasopharyngeal Sample Collection Kit; 100 pack

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : JSM

Prescription Use : Yes

Device Count : 1

Xpert Urine Specimen Collection Kit - 07332940002954 Catalog Number : URINE/A-50

Device Description : Xpert Urine Specimen Collection Kit; 50 pack

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : LIO

Prescription Use : Yes

Device Count : 1

GeneXpert Dx System - 07332940003357 Catalog Number : 900-0146

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 - 07332940003364 Catalog Number : 900-0145

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 - 07332940003371 Catalog Number : 900-0140

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 - 07332940003388 Catalog Number : 900-0138

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 - 07332940003449 Catalog Number : 900-0065

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-80 System - 07332940003814 Catalog Number : 900-0497

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Infinity-80 System - 07332940003821 Catalog Number : 900-0496

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

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