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IDS-iSYS Diluent A
EUDAMEDFDA UDIClass A (EU MDR)
Ref IS-10DAModel IDS-iSYS Diluent A
Identity
- Trade Name
- IDS-iSYS Diluent A EUDAMEDFDA UDI
- Generic Name
- Immunohistochemistry antibody diluent IVD FDA UDI
- Device Name
- IS-10DA EUDAMED
- Model / Reference
- IDS-iSYS Diluent A EUDAMEDIS-10DA EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169691094 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060169691094X5 EUDAMED
- FDA Product Code
- LXG FDA UDI
- EMDN Code
- W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
- GMDN Term
- Immunohistochemistry antibody diluent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Belgium 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
IDS-iSYS Diluent A by Immunodiagnostic Systems Limited — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 5060169691094X5 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (2)
- EUDAMED 9a259ee9-2097-40d9-9e67-90cdc5961493 61 fields · synced Jun 18, 2026
- FDA UDI 41774ff7-4185-4ef4-9b12-e67f12170770 34 fields · synced May 29, 2026