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

Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (NJR) (2) System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (NQX) (2) Test, Factor Ii G20210a Mutations, Genomic Dna Pcr (NPR) (2) Test, Factor V Leiden Mutations, Genomic Dna Pcr (NPQ) (2) System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen (PEU) (1) Respiratory Virus Panel Nucleic Acid Assay System (OCC) (1) Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System (PCH) (1) System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species (NIJ) (1)

Premarket Exempt

No Yes

Clear

Xpert MRSA/SA SSTI - 07332940000189 Catalog Number : GXMRSA/SA-SSTI-10

Device Description : Xpert MRSA/SA SSTI kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : NQX

Prescription Use : Yes

Device Count : 1

Xpert MRSA - 07332940000196 Catalog Number : GXMRSA-100N-10

Device Description : Xpert MRSA kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : NQX

Prescription Use : Yes

Device Count : 1

Xpert vanA - 07332940000233 Catalog Number : GXVANA-10

Device Description : Xpert vanA kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : NIJ

Prescription Use : Yes

Device Count : 1

Xpert Factor II & Factor V - 07332940000240 Catalog Number : GXFIIFV-10

Device Description : Xpert Factor II & Factor V kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : NPR, NPQ

Prescription Use : Yes

Device Count : 1

Xpert FLU/RSV XC - 07332940000783 Catalog Number : GXFLU/RSV-10

Device Description : Xpert FLU/RSV XC kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OCC

Prescription Use : Yes

Device Count : 1

Xpert GBS LB - 07332940000806 Catalog Number : GXGBS-LB-120

Device Description : Xpert GBS LB kit; 120 test kit

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : NJR

Prescription Use : Yes

Device Count : 1

Xpert GBS LB - 07332940000882 Catalog Number : GXGBS-LB-10

Device Description : Xpert GBS LB kit; 10 test kit

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : NJR

Prescription Use : Yes

Device Count : 1

Xpert MTB/RIF - 07332940000912 Catalog Number : GXMTB/RIF-US-10

Device Description : Xpert MTB/RIF kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : PEU

Prescription Use : Yes

Device Count : 1

Xpert HemosIL FII & FV - 07332940000936 Catalog Number : GXHEMOSIL-10

Device Description : Xpert HemosIL FII & FV kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : NPQ, NPR

Prescription Use : Yes

Device Count : 1

Xpert Norovirus - 07332940000974 Catalog Number : GXNOV-10

Device Description : Xpert Norovirus kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : PCH

Prescription Use : Yes

Device Count : 1

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