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A106 HIV-1 Ag
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 2015-0065Model 2015-0065
Identity
- Trade Name
- A106 HIV-1 Ag EUDAMEDACCURUN® FDA UDI
- Generic Name
- HIV1 antigen IVD, control FDA UDI
- Device Name
- A106 HIV-1 Ag EUDAMEDACCURUN 106 Series 1000 HIV-1 Ag 3 x 5.0 mL FDA UDI
- Model / Reference
- 2015-0065 EUDAMEDFDA UDI
- Description
- ACCURUN 106 Series 1000 HIV-1 Ag 3 x 5.0 mL FDA UDI
Identifiers
- Catalog Number
- 2015-0065 FDA UDI
- Primary DI / UDI-DI
- 00816784020253 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020253 EUDAMED
- FDA Product Code
- MYZ FDA UDI
- EMDN Code
- W0105080803 RETROVIRUS CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- HIV1 antigen IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II 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
A106 HIV-1 Ag 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-00816784020253 | 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 fc71c573-3bab-4b97-87ef-161e129f40b3 61 fields · synced Jun 19, 2026
- FDA UDI 799a2207-883b-4f8d-9f5d-4c7ff896fb85 36 fields · synced May 30, 2026