Identity
- Trade Name
- Aptima® FDA UDI
- Generic Name
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Aptima® General Purpose Reagents, 250 test, box 2 of 2 (2°C to 8°C box). The Aptima® General Purpose Reagents (GPRs) feature Transcription-Mediated Amplification (TMA®) and Hybridization Protection Assay (HPA) technologies. Aptima® GPRs may be used to facilitate the development of tests by CLIA-certified high complexity laboratories or research laboratories for the qualitative detection of nucleic acid-based analytes. FDA UDI
- Model / Reference
- APTIMA GPRS, 250 TESTS (REF) FDA UDI
- Description
- Aptima® General Purpose Reagents, 250 test, box 2 of 2 (2°C to 8°C box). The Aptima® General Purpose Reagents (GPRs) feature Transcription-Mediated Amplification (TMA®) and Hybridization Protection Assay (HPA) technologies. Aptima® GPRs may be used to facilitate the development of tests by CLIA-certified high complexity laboratories or research laboratories for the qualitative detection of nucleic acid-based analytes. FDA UDI
Identifiers
- Catalog Number
- 302071 FDA UDI
- Primary DI / UDI-DI
- 15420045506442 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® by Hologic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).
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- BD CTGCTV2 — BECTON DICKINSON AND COMPANY · Class I
- RealTime — Abbott Molecular · 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 d397d8dd-bb3f-4a4a-9f12-1d12c2f89b35 36 fields · synced May 30, 2026