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ACCURUN 381 HPV Type 16 and 18 mRNA Positive Control
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 2025-0060
Identity
- Trade Name
- ACCURUN 381 HPV Type 16 and 18 mRNA Positive Control EUDAMEDACCURUN® FDA UDI
- Generic Name
- Human papillomavirus (HPV) nucleic acid IVD, control FDA UDI
- Device Name
- ACCURUN 381 HPV Type 16 and 18 mRNA Positive Control EUDAMEDACCURUN 381 HPV TYPE 16 & 18 mRNA 10 x 1.0 mL - HPV Type 16 10 x 1.0 mL - HPV Type 18 FDA UDI
- Model / Reference
- 2025-0060 EUDAMEDFDA UDI
- Description
- ACCURUN 381 HPV TYPE 16 & 18 mRNA 10 x 1.0 mL - HPV Type 16 10 x 1.0 mL - HPV Type 18 FDA UDI
Identifiers
- Catalog Number
- 2025-0060 FDA UDI
- Primary DI / UDI-DI
- 00816784020666 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020666 EUDAMED
- FDA Product Code
- DGQ FDA UDI
- EMDN Code
- W0105080804 OTHER VIROLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Human papillomavirus (HPV) nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class IVD General 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 381 HPV Type 16 and 18 mRNA Positive Control by LGC Clinical Diagnostics, Inc. — Class IVD General — 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-00816784020666 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | 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 a0915fe2-ee7c-4f89-855c-38cda9cc954a 61 fields · synced Jul 10, 2026
- FDA UDI 86063750-7f73-4b28-8580-0eebc38ee7ba 35 fields · synced May 30, 2026