← Back to catalogue
Signal Reagent – Ev701 (reag Sgnl – Ev701)
EUDAMEDFDA UDIClass A (EU MDR)
Ref EV3601
Identity
- Trade Name
- SIGNAL REAGENT – EV701 (REAG SGNL – EV701) EUDAMEDREAG SGNL - EV701 FDA UDI
- Generic Name
- Chemiluminescent immunoassay signal generation kit IVD FDA UDI
- Device Name
- SIGNAL REAGENTS (REAG SGNL) EUDAMEDChemiluminescent substrate comprised of 1 bottle of Luminol Reagent - EV701 and 1 bottle of Peroxide Reagent. The analyser uses a 1:1 mixture of the two solutions as a working signal reagent - EV701 to generate a chemiluminescent signal which can be detected by the imaging module of the Evidence™ analyser. FDA UDI
- Model / Reference
- EV3601 EUDAMEDFDA UDI
- Description
- Chemiluminescent substrate comprised of 1 bottle of Luminol Reagent - EV701 and 1 bottle of Peroxide Reagent. The analyser uses a 1:1 mixture of the two solutions as a working signal reagent - EV701 to generate a chemiluminescent signal which can be detected by the imaging module of the Evidence™ analyser. FDA UDI
Identifiers
- Catalog Number
- EV3601 FDA UDI
- Primary DI / UDI-DI
- 05055273202694 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732AREASGN020F8 EUDAMED
- 510(k) Number
- K030360 FDA UDI
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
- GMDN Term
- Chemiluminescent immunoassay signal generation kit IVD 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Signal Reagent – Ev701 (reag Sgnl – Ev701) by Randox Laboratories Limited — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 50552732AREASGN020F8 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED 61051d74-9aa5-40e8-82e8-20fc57bd0d26 61 fields · synced Jul 10, 2026
- FDA UDI d5eee930-1f26-4949-9ed7-acace5d24d77 37 fields · synced May 30, 2026