← Back to catalogue
Optilite® Beta-2 Microglobulin Urine Control Pack
EUDAMEDFDA UDIClass B (EU MDR)
Ref NQ043.L.OPTModel LK043.L.OPT
Identity
- Trade Name
- Optilite® Beta-2 Microglobulin Urine Control Pack EUDAMEDFDA UDI
- Generic Name
- Beta-2-microglobulin IVD, control FDA UDI
- Device Name
- Optilite® Beta-2 Microglobulin Urine Kit EUDAMED
- Model / Reference
- LK043.L.OPT EUDAMEDNQ043.L.OPT EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700019057 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051700LK043.L.OPTJL EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN EUDAMED
- GMDN Term
- Beta-2-microglobulin IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Beta-2-microglobulin IVD, reagent
Optilite® Beta-2 Microglobulin Urine Control Pack by The Binding Site Group Ltd. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Beta-2-microglobulin IVD, reagent.
- Beta 2 Microglobulin (β2-MG) Test Kit (Immunofluorescence Method) — WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- Beta2-microglobulin urine — Diagam S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- Beta2-microglobulin urine — Diagam S.A. · IVD General
- Beta2-microglobulin — Diagam S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- BETA2-Microglobulin (BETA2-MG) Test — Beijing Jinwofu Bioengineering Technology Co., Ltd. · IVD General
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 | 5051700LK043.L.OPTJL | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Binding Site Group Ltd
- EUDAMED SRN
- UK-MF-000036707
- Authorised Representative
- The Binding Site Ireland Limited IE-AR-000034426
Sources (2)
- EUDAMED 2a26f3d7-fce2-433b-a4b6-497e4c6e441c 61 fields · synced Jul 13, 2026
- FDA UDI 6be9e6f9-84cb-4484-9120-bf423ec84191 34 fields · synced May 30, 2026