Identity
- Trade Name
- ANTI-BACTERIAL DETERGENT (Detergent) EUDAMEDFDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- ANTI-BACTERIAL DETERGENT (Detergent) EUDAMEDAntibacterial Detergent is used for cleaning the instrument probe and reaction cuvettes. FDA UDI
- Model / Reference
- RX8106 EUDAMEDFDA UDI
- Description
- Antibacterial Detergent is used for cleaning the instrument probe and reaction cuvettes. FDA UDI
Identifiers
- Catalog Number
- RX8106 FDA UDI
- Primary DI / UDI-DI
- 05055273210378 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732AANBDET0363V EUDAMED
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W0201010185 CHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2160 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
No
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
ANTI-BACTERIAL DETERGENT (Detergent) by Randox Laboratories 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 | 50552732AANBDET0363V | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED bc3cab23-2838-4bf3-9ebb-95810a29dd15 61 fields · synced Jul 29, 2026
- FDA UDI b92b4619-da8c-4ef4-9a35-da00d39d1002 36 fields · synced May 30, 2026