← Back to catalogue
ACCURUN 841 CT/NG Negative Control
EUDAMEDFDA UDIClass IVD Annex II List B (EU MDR)
Ref 2025-0061
Identity
- Trade Name
- ACCURUN 841 CT/NG Negative Control EUDAMEDACCURUN® FDA UDI
- Generic Name
- Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI
- Device Name
- ACCURUN 841 CT/NG Negative Control EUDAMEDACCURUN 841 CT/NG 5 x 1.0 mL FDA UDI
- Model / Reference
- 2025-0061 EUDAMEDFDA UDI
- Description
- ACCURUN 841 CT/NG 5 x 1.0 mL FDA UDI
Identifiers
- Catalog Number
- 2025-0061 FDA UDI
- Primary DI / UDI-DI
- 00816784020673 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020673 EUDAMED
- FDA Product Code
- DGQ FDA UDI
- EMDN Code
- W0105080801 BACTERIOLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class IVD Annex II List B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.5700 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
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
ACCURUN 841 CT/NG Negative Control by LGC Clinical Diagnostics, Inc. — Class IVD Annex II List B — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00816784020673 | Class IVD Annex II List B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD Annex II List B | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000016356
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED a01e7fe2-fa3e-44a6-b49b-22f72e805cf5 61 fields · synced Jul 19, 2026
- FDA UDI 810d3e49-48b2-41ec-ba27-b8a27a3c3dd1 35 fields · synced May 30, 2026