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

Real Time Nucleic Acid Amplification System (OOI) (7) 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification (OQW) (1) Respiratory Virus Panel Nucleic Acid Assay System (OCC) (1) System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen (POC) (1) System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony (PMY) (1) Trichomonas Vaginalis Nucleic Acid Amplification Test System (OUY) (1)

Premarket Exempt

No Yes

Clear

Xpert TV - 07332940001001 Catalog Number : GXTV-10

Device Description : Xpert TV kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OUY

Prescription Use : Yes

Device Count : 1

Xpert Carba-R - 07332940001032 Catalog Number : GXCARBAR-10

Device Description : Xpert Carba-R test; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : POC, PMY

Prescription Use : Yes

Device Count : 1

Xpert Flu - 07332940001070 Catalog Number : GXFLU-10A

Device Description : Xpert Flu kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OQW, OCC

Prescription Use : Yes

Device Count : 1

GeneXpert Dx System - 07332940001360 Catalog Number : 900-0490

Device Description : Additional catalog number: 900-0490R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940001377 Catalog Number : 900-0485

Device Description : Other Brand Name: GeneXpert Xpress System; Other Version or Model Number: GXII-CLIA-L

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940001384 Catalog Number : 900-0513

Device Description : Other Brand Name: GeneXpert Xpress System; Other Version or Model Number: GXIV-C Other Brand Name: GeneXpert Xpress System; Other Version or Model Number: GXIV-CLIA-LAdditional catalog numbers: 900-0513-HE, 900-0513R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940001414 Catalog Number : 900-0505

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940001421 Catalog Number : 900-0510

Device Description : Additional catalog numbers: 900-0510-HE, 900-0510R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940001438 Catalog Number : 900-0511

Device Description : Additional catalog numbers: 900-0511-HE, 900-0511R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940001445 Catalog Number : 900-0512

Device Description : Additional catalog numbers: 900-0512-HE, 900-0512R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

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