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

Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (NJR) (6) Real Time Nucleic Acid Amplification System (OOI) (5)

Premarket Exempt

Yes No

Clear

GeneXpert Dx System - 07332940004361 Catalog Number : 900-0523

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

Certified Pre-Owned GeneXpert Dx System - 07332940004378 Catalog Number : 900-0521R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Certified Pre-Owned GeneXpert Dx System - 07332940004385 Catalog Number : 900-0520R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Certified Pre-Owned GeneXpert Dx System - 07332940004392 Catalog Number : 900-0519R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Certified Pre-Owned GeneXpert Dx System - 07332940004408 Catalog Number : 900-0518R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

SmartCycler Dx System - 07332940004521 Catalog Number : SC2500N16-1

Device Description : SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : NJR

Prescription Use : Yes

Device Count : 1

SmartCycler Dx System - 07332940004538 Catalog Number : SC2500N15-1

Device Description : SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : NJR

Prescription Use : Yes

Device Count : 1

SmartCycler Dx System - 07332940004545 Catalog Number : SC2500N14-1

Device Description : SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : NJR

Prescription Use : Yes

Device Count : 1

SmartCycler Dx System - 07332940004569 Catalog Number : SC2500N13-1

Device Description : SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : NJR

Prescription Use : Yes

Device Count : 1

SmartCycler Dx System - 07332940004583 Catalog Number : SC2500N12-1

Device Description : SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : NJR

Prescription Use : Yes

Device Count : 1

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