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

Real Time Nucleic Acid Amplification System (OOI) (4) System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (NQX) (3) Dna Probe, Nucleic Acid Amplification, Chlamydia (MKZ) (1) Dna-Reagents, Neisseria (LSL) (1) Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System (PGX) (1) Multi-Analyte Controls Unassayed (OHQ) (1)

Premarket Exempt

No Yes

Clear

GeneXpert Dx System - 07332940001452 Catalog Number : 900-0518

Device Description : Additional Catalog numbers: 900-0518-1, 900-0518-2, 900-0518-3, 900-0518-6

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940001469 Catalog Number : 900-0519

Device Description : Additional catalog number: 900-0519R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940001476 Catalog Number : 900-0520

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

GeneXpert Dx System - 07332940001483 Catalog Number : 900-0521

Device Description : Additional catalog numbers: 900-0521-14, 900-0521R

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : OOI

Prescription Use : No

Device Count : 1

Xpert MRSA NxG - 07332940001711 Catalog Number : GXMRSA-NXG-10

Device Description : Xpert MRSA NxG kit; 10 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : NQX

Prescription Use : Yes

Device Count : 1

Xpert MRSA NxG - 07332940001728 Catalog Number : GXMRSA-NXG-120

Device Description : Xpert MRSA NxG kit: 120 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : NQX

Prescription Use : Yes

Device Count : 1

Xpert Check - 07332940001872 Catalog Number : XPERTCHECK-US-5

Device Description : Xpert Check; 5 each per kit

Device Class : 1

Duns Number: 956711444

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Xpert CT/NG - 07332940002350 Catalog Number : GXCT/NG-120

Device Description : Xpert CT/NG kit; 120 test kit

Device Class : 1

Duns Number: 956711444

Premarket Exempt : No

Product Code : MKZ, LSL

Prescription Use : Yes

Device Count : 1

Xpert MRSA - 07332940002442 Catalog Number : GXMRSA-120

Device Description : Xpert MRSA kit; 120 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : NQX

Prescription Use : Yes

Device Count : 1

Xpert Xpress Strep A - 07332940002503 Catalog Number : XPRSTREPA-120

Device Description : Xpert Xpress Strep A kit; 120 test kit

Device Class : 2

Duns Number: 956711444

Premarket Exempt : No

Product Code : PGX

Prescription Use : Yes

Device Count : 1

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