Identity
- Trade Name
- Aptima Combo 2® FDA UDI
- Generic Name
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Aptima Combo 2® Assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® System as specified. FDA UDI
- Model / Reference
- KIT, BX 2 (RT) AC2, 100T, AS, IVD FDA UDI
- Description
- Aptima Combo 2® Assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® System as specified. FDA UDI
Identifiers
- Catalog Number
- 302939 FDA UDI
- Primary DI / UDI-DI
- 15420045505728 FDA UDI
- FDA Product Code
- QEP FDA UDIMKZ FDA UDINSU FDA UDILSL FDA UDI
- GMDN Term
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3393 FDA UDI866.3120 FDA UDI862.2570 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: Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima Combo 2® by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI 8d5a2fda-6a16-4dec-a7a7-ff220d61c96a 36 fields · synced May 30, 2026