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ACCURUN 315 Series 200 HIV-1 RNA
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 2020-0090Model 2020-0090
Identity
- Trade Name
- ACCURUN 315 Series 200 HIV-1 RNA EUDAMEDACCURUN® FDA UDI
- Generic Name
- HIV1 nucleic acid IVD, control FDA UDI
- Device Name
- ACCURUN 315 Series 200 HIV-1 RNA EUDAMEDACCURUN 315 Series 200 HIV-1 RNA 5 x 1.0 mL FDA UDI
- Model / Reference
- 2020-0090 EUDAMEDFDA UDI
- Description
- ACCURUN 315 Series 200 HIV-1 RNA 5 x 1.0 mL FDA UDI
Identifiers
- Catalog Number
- 2020-0090 FDA UDI
- Primary DI / UDI-DI
- 00816784020567 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020567 EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0105080803 RETROVIRUS CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- HIV1 nucleic acid 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ACCURUN 315 Series 200 HIV-1 RNA 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-00816784020567 | 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 64cb1b8b-7bbf-4205-a592-bd158cbf3b9f 61 fields · synced Jul 15, 2026
- FDA UDI 6fcc0ad0-c071-4e48-8da6-7b11da6a3c9d 36 fields · synced May 30, 2026