Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit— 510(k) K151565
Substantially EquivalentCepheid
FDA 510(k) clearance K151565 for Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit, Substantially Equivalent on 2015-10-16. Applicant: Cepheid. Device class: 2.
Clearance details
- Applicant
- Cepheid
- Product code
- Code OUY
- Device class
- Class 2
- Regulation
- 21 CFR 866.3860
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code OUY
view all- K231316 — Aptima Trichomonas vaginalis Assay
- K182692 — BD MAX CTGCTV2, BD MAX System
- K151589 — BD MAX CT/GC/TV, BD MAX INSTRUMENT
- K161619 — Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems
- K161182 — Solana Trichomonas Assay
More clearances from Cepheid
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