Identity
- Trade Name
- Aptima® FDA UDI
- Generic Name
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical FDA UDI
- Device Name
- The Aptima® Specimen Transfer Kit consists of transfer tubes containing specimen transport medium (STM) and is intended for use with Aptima® assays. Refer to the appropriate product package insert for the indicated uses of the Aptima® Specimen Transfer Kit for each Hologic product. FDA UDI
- Model / Reference
- APTIMA LIQUID PAP TRANSFER TUBES, IVD KIT FDA UDI
- Description
- The Aptima® Specimen Transfer Kit consists of transfer tubes containing specimen transport medium (STM) and is intended for use with Aptima® assays. Refer to the appropriate product package insert for the indicated uses of the Aptima® Specimen Transfer Kit for each Hologic product. FDA UDI
Identifiers
- Catalog Number
- 301154C FDA UDI
- Primary DI / UDI-DI
- 15420045500297 FDA UDI
- FDA Product Code
- NSU FDA UDIMKZ FDA UDILSL FDA UDI
- GMDN Term
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 FDA UDI866.3120 FDA UDI866.3390 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 II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical.
- Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack — Visby Medical, Inc. · Class II
- Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays — BECTON DICKINSON AND COMPANY · Class II
- cobas® PCR Urine Sample Kit — Roche Molecular Systems, Inc. · Class II
- BD Vaginal Specimen Transport for the BD ProbeTec™ Qx Amplified DNA Assays — BECTON DICKINSON AND COMPANY · Class II
- Visby Medical Power Adapter — Visby Medical, Inc. · Class II
- binx io — Binx Health, Inc. · Class I
- BD Molecular Swab Collection Kit — BECTON DICKINSON AND COMPANY · Class II
- 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI 5ce5a4b7-96bf-4a14-badb-9a2879838b7d 36 fields · synced Jun 8, 2026