Identity
- Trade Name
- Aptima CV/TV Assay Controls Kit EUDAMEDAptima® FDA UDI
- Generic Name
- Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control FDA UDI
- Device Name
- Aptima CV/TV Assay EUDAMEDAptima® CV/TV Assay Controls Kit. FDA UDI
- Model / Reference
- PRD-05190 EUDAMEDCV/TV CONTROLS, APTIMA, 100T, IVD FDA UDI
- Description
- Aptima® CV/TV Assay Controls Kit. FDA UDI
Identifiers
- Catalog Number
- PRD-05190 FDA UDI
- Primary DI / UDI-DI
- 15420045512092 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455DIAGAPTCVTV2E EUDAMED
- Unit of Use DI
- 05420045512095 EUDAMED
- 510(k) Number
- K190472 FDA UDI
- FDA Product Code
- PQA FDA UDINSU FDA UDI
- EMDN Code
- W0105080899 CONTROLS - INF. IMMUNOLOGY - OTHER EUDAMED
- GMDN Term
- Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3975 FDA UDI862.2570 FDA UDI
- Market of Registration
- Belgium EUDAMED
- 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
Category: Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
Aptima® by Hologic, Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K190472 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 4a197ea8-d1b4-4c8f-a383-2a130ce4ed85 37 fields · synced Jul 9, 2026
- EUDAMED c22de9c3-f369-4ee6-96c1-b2dee807a024 61 fields · synced Jul 9, 2026