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I.s.e. Urine Diluent (ise Dil Urn)

EUDAMEDFDA UDI

Class A (EU MDR)

Ref RX3950

by Randox Laboratories Limited

Identity

Trade Name
I.S.E. URINE DILUENT (ISE DIL URN) EUDAMED
ISE DIL URN FDA UDI
Generic Name
Buffered sample diluent IVD FDA UDI
Device Name
I.S.E. URINE DILUENT (ISE DIL URN) EUDAMED
The product is required for urine samples. Urine samples must be diluted by a factor of 10 to perform urine measurement. The host analyser will mix the diluent and sample before dispensing the diluted sample into the ISE module. FDA UDI
Model / Reference
RX3950 EUDAMEDFDA UDI
Description
The product is required for urine samples. Urine samples must be diluted by a factor of 10 to perform urine measurement. The host analyser will mix the diluent and sample before dispensing the diluted sample into the ISE module. FDA UDI

Identifiers

Catalog Number
RX3950 FDA UDI
Primary DI / UDI-DI
05055273205961 EUDAMEDFDA UDI
Basic UDI-DI
50552732AISEDIL005DG EUDAMED
FDA Product Code
JJF FDA UDI
EMDN Code
W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
GMDN Term
Buffered sample diluent IVD FDA UDI

Classification

Device Class
Class A EUDAMED
Class I FDA UDI
Regulation Number
862.2170 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

I.s.e. Urine Diluent (ise Dil Urn) 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

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Manufacturer

Manufacturer
Randox Laboratories Limited
EUDAMED SRN
XI-MF-000028410

Sources (2)

  • EUDAMED 3f492b49-e2d8-4436-84a7-2511d393fde7 61 fields · synced Jul 10, 2026
  • FDA UDI 83e7347b-0844-4f35-a9cf-614f14e680b0 36 fields · synced May 29, 2026