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ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100
EUDAMEDFDA UDIClass IVD Annex II List B (EU MDR)
Ref 2025-0067
Identity
- Trade Name
- ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100 EUDAMEDACCURUN® FDA UDI
- Generic Name
- Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI
- Device Name
- ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100 EUDAMEDACCURUN 342 Series 100 CT/NG 10 x 1.0 mL FDA UDI
- Model / Reference
- 2025-0067 EUDAMEDFDA UDI
- Description
- ACCURUN 342 Series 100 CT/NG 10 x 1.0 mL FDA UDI
Identifiers
- Catalog Number
- 2025-0067 FDA UDI
- Primary DI / UDI-DI
- 00816784020680 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020680 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 342 CT/NG Nucleic Acid Positive Control Series 100 by LGC Clinical Diagnostics, Inc. — Class IVD Annex II List B — IVDD, FDA UDI — listed in EUDAMED…
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-00816784020680 | Class IVD Annex II List B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD Annex II List B | Pending data |
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Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000016356
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 854e5fca-3c2b-4322-895b-9776337eed26 61 fields · synced Jun 18, 2026
- FDA UDI 9e8eaa38-df69-4571-9a15-43b4dac07288 35 fields · synced May 30, 2026