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Aptima Trichomonas vaginalis Controls Kit
EUDAMEDFDA UDIClass C (EU MDR)
Ref 302807
by Hologic
Identity
- Trade Name
- Aptima Trichomonas vaginalis Controls Kit EUDAMEDAptima® FDA UDI
- Generic Name
- Trichomonas vaginalis nucleic acid IVD, control FDA UDI
- Device Name
- Aptima Trichomonas vaginalis Assay EUDAMEDAptima® Trichomonas vaginalis Controls Kit. FDA UDI
- Model / Reference
- 302807 EUDAMEDKIT, CONTROLS, ATV, 250 CE FDA UDI
- Description
- Aptima® Trichomonas vaginalis Controls Kit. FDA UDI
Identifiers
- Catalog Number
- 302807 FDA UDI
- Primary DI / UDI-DI
- 15420045505766 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455DIAGAPTTRICHWY EUDAMED
- Unit of Use DI
- 05420045505769 EUDAMED
- FDA Product Code
- OUY FDA UDI
- EMDN Code
- W0105080805 PARASITOLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Trichomonas vaginalis nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3860 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Aptima Trichomonas vaginalis Controls Kit by Hologic Inc. — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 54200455DIAGAPTTRICHWY | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- Hologic
- EUDAMED SRN
- US-MF-000001646
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (2)
- EUDAMED be40d82d-b742-4284-8020-8504df45e906 61 fields · synced Jun 19, 2026
- FDA UDI b249c54c-bdff-4a73-b9b5-d5ff0238a9b2 37 fields · synced May 30, 2026