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ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 2015-0093
Identity
- Trade Name
- ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000 EUDAMEDACCURUN® FDA UDI
- Generic Name
- Treponema pallidum immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Device Name
- ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000 EUDAMEDACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 3 x 2.0 mL FDA UDI
- Model / Reference
- 2015-0093 EUDAMEDFDA UDI
- Description
- ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 3 x 2.0 mL FDA UDI
Identifiers
- Catalog Number
- 2015-0093 FDA UDI
- Primary DI / UDI-DI
- 00816784020475 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020475 EUDAMED
- FDA Product Code
- KSF FDA UDI
- EMDN Code
- W0105080801 BACTERIOLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Treponema pallidum immunoglobulin G (IgG) antibody IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9650 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
Dimensions & Sizes
- Size
- Total Volume — 6 Milliliter FDA UDI
ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000 by LGC Clinical Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED…
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-00816784020475 | 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 250b25c8-6c66-455b-8919-15526e4e9eb7 61 fields · synced Jul 18, 2026
- FDA UDI 505e4c44-7d87-4976-be58-0c2be7954dbd 37 fields · synced May 29, 2026