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

System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (NQX) (3) C. Difficile Nucleic Acid Amplification Test Assay (OMN) (2) Reagents, Clostridium Difficile Toxin (LLH) (2) Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (NJR) (1) Dna-Reagents, Neisseria (LSL) (1) Dna Probe, Nucleic Acid Amplification, Chlamydia (MKZ) (1) Assay, Enterovirus Nucleic Acid (OAI) (1)

Premarket Exempt

No Yes

Clear

Xpert C. difficile/Epi - 07332940000028 Catalog Number : GXCDIFF/EPI-10

Device Description : Xpert C. difficile/Epi test; 10 test kit

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : OMN

Prescription Use : Yes

Device Count : 1

Xpert C. difficile - 07332940000035 Catalog Number : GXCDIFFICILE-10

Device Description : Xpert C. difficile test; 10 test kit

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : LLH

Prescription Use : Yes

Device Count : 1

Xpert C. difficile/Epi - 07332940000042 Catalog Number : GXCDIFF/EPI-120

Device Description : Xpert C. difficile/Epi kit; 120 test kit

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : OMN

Prescription Use : Yes

Device Count : 1

Xpert C. difficile - 07332940000059 Catalog Number : GXCDIFFICILE-120

Device Description : Xpert C. difficile test; 120 test kit

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : LLH

Prescription Use : Yes

Device Count : 1

Xpert CT/NG - 07332940000080 Catalog Number : GXCT/NG-10

Device Description : Xpert CT/NG kit; 10 test kit

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : MKZ, LSL

Prescription Use : Yes

Device Count : 1

Xpert EV - 07332940000097 Catalog Number : GXEV-100N-10

Device Description : Xpert EV kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OAI

Prescription Use : Yes

Device Count : 1

Xpert GBS - 07332940000127 Catalog Number : GXGBS-100N-10

Device Description : Xpert GBS kit; 10 test kit

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : NJR

Prescription Use : Yes

Device Count : 1

Xpert MRSA/SA Blood Culture - 07332940000141 Catalog Number : GXMRSA/SA-BC-10

Device Description : Xpert MRSA/SA Blood Culture kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : NQX

Prescription Use : Yes

Device Count : 1

Xpert SA Nasal Complete - 07332940000158 Catalog Number : GXSACOMP-10

Device Description : Xpert SA Nasal Complete kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : NQX

Prescription Use : Yes

Device Count : 1

Xpert SA Nasal Complete - 07332940000165 Catalog Number : GXSACOMP-120

Device Description : Xpert SA Nasal Complete kit; 120 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : NQX

Prescription Use : Yes

Device Count : 1

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