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RNA QC 253 Level 1

by Rna Medical Division

Ref QC253

RNA QC 253 Level 1 (QC 253-1) is an in vitro diagnostic device (EU IVDD general IVD) made by Rna Medical Division, registered in EUDAMED on 27 May 2026 (Basic UDI-DI B-10851290002451) and listed in FDA GUDID since 3 Jun 2019 (UDI-DI 10851290002451), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-10851290002451 Basic UDI-DI 10851290002451UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10851290002451 UDI-DI Date3 Jun 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10851290002451 registered 27 May 2026 Active
  • FDA GUDID UDI-DI 10851290002451 listed 3 Jun 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10851290002451
  2. Registered EUDAMED B-10851290002451

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
RNA Medical® Full Range CO-Oximeter Control -level 1 EUDAMED
RNA GUDID
Generic name
Total haemoglobin (totHb) IVD, control
Device name
RNA Medical® Full Range CO-Oximeter Control-level 1
Model / Ref / Catalog
QC253 EUDAMED
QC 253 Level 1 GUDID
QC 253-1 GUDID
Primary DI / UDI-DI
10851290002451
Basic UDI-DI
B-10851290002451
EMDN code
W0101050101 Assayed multicomponent controls (cc)
GMDN term
Total haemoglobin (totHb) IVD, control
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
QC253
GUDID
QC 253 Level 1

Related devices

Category: Total haemoglobin (totHb) IVD, control

Similar devices in this category

Other devices filed under ASSAYED MULTICOMPONENT CONTROLS (CC).

Other devices from Rna Medical Division

See all devices from Rna Medical Division →

Properties

  • Contains animal tissues or cells
  • Near-patient testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)