Identity
- Trade Name
- Aptima® FDA UDI
- Generic Name
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical FDA UDI
- Device Name
- Aptima® Specimen Transfer Kit, 100 test. FDA UDI
- Model / Reference
- Aptima Specimen Transfer for Liquid Pap FDA UDI
- Description
- Aptima® Specimen Transfer Kit, 100 test. FDA UDI
Identifiers
- Catalog Number
- PRD-05110 FDA UDI
- Primary DI / UDI-DI
- 15420045511880 FDA UDI
- FDA Product Code
- MKZ FDA UDILSL FDA UDINSU FDA UDI
- GMDN Term
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3120 FDA UDI866.3390 FDA UDI862.2570 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: Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
Aptima® by Hologic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical.
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- binx io — Binx Health, Inc. · Class I
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- Visby Medical Women's Sexual Health Test — Visby Medical, Inc. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI 3b7be001-b734-48b9-b792-70abdcc10938 36 fields · synced Jun 6, 2026