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) (5) Real Time Nucleic Acid Amplification System (OOI) (4) Respiratory Virus Panel Nucleic Acid Assay System (OCC) (3) Culture Media, Non-Propagating Transport (JSM) (1) Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System (PGX) (1)

Premarket Exempt

No Yes

Clear

SmartCycler Dx System - 07332940004910 Catalog Number : SC2500N17-1

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

Xpert Flu+RSV Xpress - 07332940005177 Catalog Number : GXFLU+RSV-XP-10

Device Description : Xpert Flu+RSV Xpress kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OCC

Prescription Use : Yes

Device Count : 1

Xpert Xpress Flu/RSV - 07332940005696 Catalog Number : XPRSFLU/RSV-10

Device Description : Xpert Xpress Flu/RSV kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OCC

Prescription Use : Yes

Device Count : 1

Xpert Xpress Flu - 07332940006044 Catalog Number : XPRSFLU-10

Device Description : Xpert Xpress Flu kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OCC

Prescription Use : Yes

Device Count : 1

Xpert Xpress Strep A - 07332940006372 Catalog Number : XPRSTREPA-10

Device Description : Xpert Xpress Strep A kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : PGX

Prescription Use : Yes

Device Count : 1

Xpert® - 07332940006457 Catalog Number : SWAB/F-100

Device Description : Nasal Sample Collect Kit for Viruses

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : JSM

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940006709 Catalog Number : 900-0139

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 - 07332940006716 Catalog Number : 900-0141

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 - 07332940006723 Catalog Number : 900-0144

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 - 07332940006730 Catalog Number : 900-0391

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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