Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit— 510(k) K190441
Substantially EquivalentCepheid
FDA 510(k) clearance K190441 for Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit, Substantially Equivalent on 2019-05-23. Applicant: Cepheid. Device class: 2.
Clearance details
- Applicant
- Cepheid
- Product code
- Code QEP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3393
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code QEP
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view allData sourced from openFDA. This site is unofficial and independent of the FDA.