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) (6) Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (NJR) (4) Bcr/Abl1 Monitoring Test (OYX) (1) Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (PQA) (1)

Premarket Exempt

No Yes

Clear

Xpert® - 07332940007072 Catalog Number : XPRSMVP-10

Device Description : Xpert Xpress MVP

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : PQA

Prescription Use : Yes

Device Count : 1

Xpert BCR-ABL Ultra - 07332940007102 Catalog Number : GXBCRABL-US-10

Device Description : Xpert BCR-ABL Ultra test; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OYX

Prescription Use : Yes

Device Count : 1

GeneXpert® - 07332940007195 Catalog Number : 900-0828

Device Description : Xpress System

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Xpert® - 07332940007652 Catalog Number : GXGBSLBXC-10

Device Description : GBS LB XC

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : NJR

Prescription Use : Yes

Device Count : 1

Xpert® - 07332940007669 Catalog Number : GXGBSLBXC-120

Device Description : GBS LB XC

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : NJR

Prescription Use : Yes

Device Count : 1

GeneXpert® - 07332940007683 Catalog Number : GX-II R2

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® - 07332940007690 Catalog Number : GX-IV R2

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® - 07332940007706 Catalog Number : GX-XVI R2

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® - 07332940007713 Catalog Number : GX-INFINITY 48S

Device Description : Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert® - 07332940007720 Catalog Number : GX-INFINITY 80

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

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