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Serology Lyme Disease Negative Control (lyme Control -)
EUDAMEDFDA UDIClass B (EU MDR)
Ref SR10345
Identity
- Trade Name
- SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -) EUDAMEDFDA UDI
- Generic Name
- Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control FDA UDI
- Device Name
- SEROLOGY LYME DISEASE CONTROL EUDAMEDLyme Disease Negative Control is intended for use as an unassayed non-reactive quality assurance reagent, with in vitro assays detecting IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi. FDA UDI
- Model / Reference
- SR10345 EUDAMEDFDA UDI
- Description
- Lyme Disease Negative Control is intended for use as an unassayed non-reactive quality assurance reagent, with in vitro assays detecting IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi. FDA UDI
Identifiers
- Catalog Number
- SR10345 FDA UDI
- Primary DI / UDI-DI
- 05055273216387 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732BSELYDC124N4 EUDAMED
- FDA Product Code
- MJY FDA UDI
- EMDN Code
- W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Serology Lyme Disease Negative Control (lyme Control -) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 50552732BSELYDC124N4 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED 4b36c8fc-030f-4990-9367-836af7b535d5 61 fields · synced Jul 27, 2026
- FDA UDI 3f210e40-4310-4ca4-9c38-4209aa494162 36 fields · synced May 30, 2026