Identity
- Trade Name
- Aptima® FDA UDI
- Generic Name
- Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Aptima® GC assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima® Neisseria gonorrhoeae assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease using the Tigris® DTS® System or semi-automated instrumentation as specified. FDA UDI
- Model / Reference
- KIT, BOX 1, REF, AGC, 100-T, AS, IVD FDA UDI
- Description
- Aptima® GC assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima® Neisseria gonorrhoeae assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease using the Tigris® DTS® System or semi-automated instrumentation as specified. FDA UDI
Identifiers
- Catalog Number
- 302935 FDA UDI
- Primary DI / UDI-DI
- 15420045505421 FDA UDI
- FDA Product Code
- LSL FDA UDI
- GMDN Term
- Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3390 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: Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT).
- digene® HC2 GC-ID DNA Test — QIAGEN Sciences LLC · Class II
- BD ProbeTec™ Neisseria gonorrhoeae (GC) Qx Assay Gray Amp Reagent Pack — BECTON DICKINSON AND COMPANY · Class II
- digene® HC2 CT/GC DNA Test — QIAGEN Sciences LLC · Class II
- Aptima® — Hologic, 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 |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI 16b4e99a-7972-4489-b05f-7246ef1bbe6e 36 fields · synced Jun 1, 2026