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Aptima Neisseria gonorrhoeae
EUDAMEDFDA UDIClass C (EU MDR)
Ref 302927
by Hologic
Identity
- Trade Name
- Aptima Neisseria gonorrhoeae EUDAMEDAptima® FDA UDI
- Generic Name
- Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Aptima Neisseria gonorrhoeae Assay EUDAMEDAptima® GC assay, 100 test, box 2 of 2 (15°C to 30°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
- 302927 EUDAMEDKIT, BOX 2, RT, AGC 100-T, AS, IVD FDA UDI
- Description
- Aptima® GC assay, 100 test, box 2 of 2 (15°C to 30°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
- 302943 FDA UDI
- Primary DI / UDI-DI
- 15420045505438 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455DIAGAPTGCQL EUDAMED
- Direct Marketing DI
- 15420045505438 EUDAMED
- FDA Product Code
- LSL FDA UDI
- EMDN Code
- W0105010203 GONOCOCCAL DETECTION BY NA REAGENTS EUDAMED
- GMDN Term
- Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3390 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Aptima Neisseria gonorrhoeae by Hologic Inc. — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 54200455DIAGAPTGCQL | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- Hologic
- EUDAMED SRN
- US-MF-000001646
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (2)
- EUDAMED bb9e8881-03a3-42c7-b9bd-359b0f0e4281 61 fields · synced Jul 9, 2026
- FDA UDI 7c4bebad-8a07-40f5-a0f7-bd81f7c7c52c 36 fields · synced May 30, 2026