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ACCURUN Anti-SARS-CoV-2 Series 2000
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 2015-0225
Identity
- Trade Name
- ACCURUN Anti-SARS-CoV-2 Series 2000 EUDAMEDACCURUN® Anti-SARS-CoV-2 Controls Kit Series 2000 FDA UDI
- Generic Name
- SARS-CoV-2 total antibody IVD, control FDA UDI
- Device Name
- ACCURUN Anti-SARS-CoV-2 Series 2000 EUDAMEDACCURUN® Anti-SARS-CoV-2 Controls Kit Series 2000 FDA UDI
- Model / Reference
- 2015-0225 EUDAMEDFDA UDI
- Description
- ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 2000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816784020970 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020970 EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0105080804 OTHER VIROLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- SARS-CoV-2 total antibody IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Ireland 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
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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ACCURUN Anti-SARS-CoV-2 Series 2000 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-00816784020970 | 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 ca3b68c7-fc97-4cc1-b032-24b357c014b9 61 fields · synced Jul 11, 2026
- FDA UDI c173064f-99bd-4c6a-8432-ed5f8e8f69c0 34 fields · synced May 30, 2026