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Signal Reagents – Ev805 (reag Sgnl – Ev805)

EUDAMEDFDA UDI

Class A (EU MDR)

Ref EV3529

by Randox Laboratories Limited

Identity

Trade Name
SIGNAL REAGENTS – EV805 (REAG SGNL – EV805) EUDAMED
REAG SGNL - EV805 FDA UDI
Generic Name
Chemiluminescent immunoassay signal generation kit IVD FDA UDI
Device Name
SIGNAL REAGENTS (REAG SGNL) EUDAMED
Chemiluminescent substrate comprised of 1 bottle of Luminol Reagent - EV805 and 1 bottle of Peroxide Reagent. The analyser uses a 1:1 mixture of the two solutions as a working signal reagent to generate a chemiluminescent signal which can be detected by the imaging module of the Evidence™ analyser. FDA UDI
Model / Reference
EV3529 EUDAMEDFDA UDI
Description
Chemiluminescent substrate comprised of 1 bottle of Luminol Reagent - EV805 and 1 bottle of Peroxide Reagent. The analyser uses a 1:1 mixture of the two solutions as a working signal reagent to generate a chemiluminescent signal which can be detected by the imaging module of the Evidence™ analyser. FDA UDI

Identifiers

Catalog Number
EV3529 FDA UDI
Primary DI / UDI-DI
05055273202335 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 EUDAMED
Class 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 Reagents – Ev805 (reag Sgnl – Ev805) 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

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Manufacturer

Manufacturer
Randox Laboratories Limited
EUDAMED SRN
XI-MF-000028410

Sources (2)

  • EUDAMED aae1dfb5-c6fb-4798-a615-f729f5466b68 61 fields · synced Jul 15, 2026
  • FDA UDI cdbae7cd-e9be-42b9-9cc8-8144e1f2d328 37 fields · synced May 30, 2026