Optilite® IgG Control Pack
EUDAMEDFDA UDIClass B (EU MDR)
Identity
- Trade Name
- Optilite® IgG Control Pack EUDAMEDFDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, control FDA UDI
- Device Name
- Optilite® IgG Kit EUDAMED
- Model / Reference
- NK004.OPT EUDAMEDNQ004.OPT EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700019095 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051700NK004.OPT4U EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
- GMDN Term
- Total immunoglobulin G (IgG total) 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Optilite® IgG Control Pack by The Binding Site Group Ltd. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5051700NK004.OPT4U | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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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 2332ff7c-8763-4977-9cd2-b69de28f1561 61 fields · synced Oct 6, 2026
- FDA UDI 5d1d71b8-22f8-4112-9f87-54657a02554f 34 fields · synced May 30, 2026