← Back to catalogue
Optilite® Hevylite® IgG Lambda Control Pack
EUDAMEDClass C (EU MDR)
Ref NQ622.OPTModel NK622.OPT
Identity
- Trade Name
- Optilite® Hevylite® IgG Lambda Control Pack EUDAMED
- Device Name
- Optilite® Hevylite® IgG Lambda Kit EUDAMED
- Model / Reference
- NK622.OPT EUDAMEDNQ622.OPT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051700019415 EUDAMED
- Basic UDI-DI
- 5051700NK622.OPT86 EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Optilite® Hevylite® IgG Lambda Control Pack by The Binding Site Group Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD.
- Horizon — BECTON DICKINSON AND COMPANY · Class I
- PRESTIGE 24i IgG — PZ CORMAY Spółka Akcyjna · IVD General
- Horizon — BECTON DICKINSON AND COMPANY · Class I
- Immunoglobulin G Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- IGG — Medicon Hellas SA · Class B
- A-400 IgG — PZ CORMAY Spółka Akcyjna · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5051700NK622.OPT86 | Class C | Active |
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 (1)
- EUDAMED 9808598b-c4d7-400c-bdc6-7575d514e308 61 fields · synced Oct 9, 2026