Skip to content

Streck Cell Preservative

by Streck 3 variants

Ref 213350

Streck Cell Preservative (213350) is a lymphocyte stabilization reagent IVD (EU IVDR Class A; FDA Class I; FDA product code LEA, Preservative, Cytological) made by Streck, registered in EUDAMED on 23 May 2022 (Basic UDI-DI 08445090CY93) and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 10844509000843), active as of 22 Oct 2026.

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

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number08445090CY93 Basic UDI-DI 10844509000843UDI-DIDate23 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number10844509000843 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08445090CY93 registered 23 May 2022 Active
  • FDA GUDID UDI-DI 10844509000843 listed 19 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 10844509000843
  2. Registered EUDAMED 08445090CY93

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Lymphocyte stabilization reagent IVD
Model / Ref / Catalog
213350
Primary DI / UDI-DI
10844509000843
Basic UDI-DI
08445090CY93
Unit of use DI
00844509000846
FDA product code
LEA
EMDN code
W01030406 Lymphocyte stabilizing media
GMDN term
Lymphocyte stabilization reagent IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.4010
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1.0 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000013009
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

Similar devices in this category

Other devices filed under TISSUE TYPING REAGENTS.

Other devices from Streck

See all devices from Streck →

Properties

  • Single use
  • Reagent
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)