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DISPLACEMENT FLUID CONCENTRATE (DISP FL (conc.))

EUDAMEDFDA UDI

Class A (EU MDR)

Ref EV3580

by Randox Laboratories Limited

Identity

Trade Name
DISPLACEMENT FLUID CONCENTRATE (DISP FL (conc.)) EUDAMED
DISP FL (conc.) FDA UDI
Generic Name
Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Device Name
DISPLACEMENT FLUID CONCENTRATE (DISP FL (conc.)) EUDAMED
Diluted displacement fluid is used to wash the Evidence™ reagent tubing between dispenses. FDA UDI
Model / Reference
EV3580 EUDAMEDFDA UDI
Description
Diluted displacement fluid is used to wash the Evidence™ reagent tubing between dispenses. FDA UDI

Identifiers

Catalog Number
EV3580 FDA UDI
Primary DI / UDI-DI
05055273202656 EUDAMEDFDA UDI
Basic UDI-DI
50552732ADISFLU049FT EUDAMED
510(k) Number
K030360 FDA UDI
FDA Product Code
JJE FDA UDI
EMDN Code
W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
GMDN Term
Wash/cleaning solution IVD, automated/semi-automated system 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

DISPLACEMENT FLUID CONCENTRATE (DISP FL (conc.)) 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 5f017336-0255-4efb-b0c6-68c74328b330 61 fields · synced Jun 18, 2026
  • FDA UDI 869c4687-6b49-421f-b056-37402242535c 37 fields · synced May 30, 2026