Aptima CV/TV Assay
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Aptima CV/TV Assay EUDAMEDAptima® FDA UDI
- Generic Name
- Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Aptima CV/TV Assay EUDAMEDAptima® CV/TV assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. FDA UDI
- Model / Reference
- PRD-05189 EUDAMEDKIT, BOX 1, REFRIGERATED, ACV/TV, 100T, IVD FDA UDI
- Description
- Aptima® CV/TV assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. FDA UDI
Identifiers
- Catalog Number
- ASY-11569 FDA UDI
- Primary DI / UDI-DI
- 15420045512061 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455DIAGAPTCVTV2E EUDAMED
- Direct Marketing DI
- 15420045512061 EUDAMED
- 510(k) Number
- FDA Product Code
- PQA FDA 510(k)FDA UDINSU FDA UDI
- EMDN Code
- W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS EUDAMED
- GMDN Term
- Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 866.3975 FDA 510(k)
- Regulation Number
- 866.3975 FDA 510(k)FDA UDI862.2570 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The Aptima CV/TV Assay is a Vaginitis and Bacterial Vaginosis Nucleic Acid Detection System, designed for the molecular detection of Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) in clinical specimens. It employs nucleic acid amplification technology to identify these pathogens, aiding in the diagnosis of sexually transmitted infections and bacterial vaginosis.
This in vitro diagnostic device is intended for laboratory use and is supplied as a single-use reagent kit. It requires no additional sterilisation beyond its pre-packaged, sterile components and is classified as a Class II medical device under FDA regulations. The assay is authorised for use in microbiology settings and complies with both FDA 510(k) clearance and EU IVDR requirements. Storage conditions are specified in the accompanying instructions for use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K190472 | Class II | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (3)
- FDA 510(k) K190472 24 fields · synced Sep 18, 2026
- FDA UDI ffdfd73c-26cc-4a3a-a250-efc60be2b555 37 fields · synced May 30, 2026
- EUDAMED 746ebfad-e122-4876-9a65-ad6987706471 61 fields · synced Jul 10, 2026