FLEX Polyclonal Rabbit Anti-Human CD3, Ready-to-Use (Link)

by Agilent Technologies Singapore (International) Pte Ltd Singapore EUDAMED

Ref IR50361-2Model IR503 EMDN W0102030199

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-SGMF000014448IR503619Y Basic UDI-DI	Date24 Aug 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference: IR503, IR50361-2

Primary DI / UDI-DI: D-SGMF000014448IR503619Y
Basic UDI-DI: B-SGMF000014448IR503619Y
EMDN Code: W0102030199 Cancer antigens - other

Device Class: Class IVD General
Market of Registration: Denmark

Manufacturer details

EUDAMED SRN: SG-MF-000014448
Authorised representative: Agilent Technologies Denmark ApS DK-AR-000001443

Other devices from Agilent Technologies Singapore (International) Pte Ltd

Dako Mounting Medium

Class A
FLEX Monoclonal Mouse Anti-Human Hepatocyte, Clone OCH1E5, Ready-to-Use (Dako Omnis)

IVD General
EnVision FLEX Hematoxylin (Link)

Class A
EnVision FLEX Target Retrieval Solution Low pH (50x)

Class A
ISH Pre-Treatment Solution (20x) (Dako Omnis)

Class A
FLEX Monoclonal Mouse Anti-Human Synaptophysin, Clone DAK-SYNAP, Ready-to-Use (Link)

IVD General

See all devices from Agilent Technologies Singapore (International) Pte Ltd →

Properties & raw data

Show properties, registry sources and raw records

Reagent
Professional Testing

Other properties (9)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No

Sources (1)

EUDAMED f7bf17c0-8527-4360-8149-34b132aea2e0 61 fields · synced 24 Oct 2026