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A127 Anti-Delta
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 2015-0079Model 2015-0079
Identity
- Trade Name
- A127 Anti-Delta EUDAMEDACCURUN® FDA UDI
- Generic Name
- Human T-cell lymphotrophic virus 2 (HTLV2) nucleic acid IVD, control FDA UDI
- Device Name
- A127 Anti-Delta EUDAMEDACCURUN 127 Anti-Hepatitis Delta 1 x 1.0 mL FDA UDI
- Model / Reference
- 2015-0079 EUDAMEDFDA UDI
- Description
- ACCURUN 127 Anti-Hepatitis Delta 1 x 1.0 mL FDA UDI
Identifiers
- Catalog Number
- 2015-0079 FDA UDI
- Primary DI / UDI-DI
- 00816784020369 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020369 EUDAMED
- FDA Product Code
- DGQ FDA UDI
- EMDN Code
- W0105080802 HEPATITIS VIRUS CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Human T-cell lymphotrophic virus 2 (HTLV2) 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
A127 Anti-Delta by LGC Clinical Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00816784020369 | 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 c5532c9e-ad2b-4387-9496-40fb446a0f9b 61 fields · synced Jun 19, 2026
- FDA UDI 8774f565-5fa1-4b7e-a7f3-711f224bfc5c 35 fields · synced May 29, 2026