Identity
- Trade Name
- Aptima® FDA UDI
- Generic Name
- Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Aptima® Trichomonas vaginalis Assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Tigris® DTS® System. FDA UDI
- Model / Reference
- KIT, ATV (RT), IVD 100 FDA UDI
- Description
- Aptima® Trichomonas vaginalis Assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Tigris® DTS® System. FDA UDI
Identifiers
- Catalog Number
- 303064 FDA UDI
- Primary DI / UDI-DI
- 15420045505469 FDA UDI
- 510(k) Number
- DEN110012 FDA UDI
- FDA Product Code
- OUY FDA UDI
- GMDN Term
- Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT).
- Solana — Quidel Corp. · Class II
- MGB Alert® Trichomonas Vaginalis Primer Mix ASR - 48 rxn — ELITechGroup MDX LLC. · Class I
- Xpert TV — CEPHEID · Class II
- Solana — Quidel Corp. · Class II
- MGB Alert® Trichomonas Vaginalis Probe Mix ASR - 48 rxn — ELITechGroup MDX LLC. · Class I
- MGB Alert Trichomonas vaginalis Primer Mix ASR, 09N42-003 — ELITechGroup MDX LLC. · Class I
- MGB Alert Trichomonas Vaginalis Probe Mix ASR, 09N42-002 — ELITechGroup MDX LLC. · Class I
- APTIMA — Hologic, Inc. · Class II
Cleared under the same submission
DEN110012 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI 575c9a36-bb88-4e40-8108-9f8fb7b542b0 37 fields · synced Jun 1, 2026