# Streck Cell Preservative

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/streck-cell-preservative-213350>
- Manufacturer: [Streck](https://devicerts.com/manufacturers/streck) (United States)
- Device class: Class A (EU IVDR); Class I (US FDA)
- FDA product code: LEA
- EMDN: W01030406 LYMPHOCYTE STABILIZING MEDIA
- GMDN: Lymphocyte stabilization reagent IVD (41413)

## Registrations and authorizations

- **EUDAMED** · CE/IVDR · European Union · Basic UDI-DI 08445090CY93 · UDI-DI 10844509000843 · registered 2022-05-23 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 10844509000843 · listed 2016-09-19 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Generic name: Lymphocyte stabilization reagent IVD [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 213350 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 10844509000843 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 08445090CY93 [EUDAMED]
- Unit of use DI: 00844509000846 [EUDAMED]
- FDA product code: LEA [FDA GUDID (AccessGUDID)]
- EMDN code: W01030406 [EUDAMED]
- GMDN term: Lymphocyte stabilization reagent IVD (41413) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class A [EUDAMED]; Class I [FDA GUDID (AccessGUDID)]
- Regulation number: 864.4010 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: France [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Dimensions & Sizes

- Size: Total Volume — 1.0 Milliliter [FDA GUDID (AccessGUDID)]

## Properties

- Single use: Yes [FDA GUDID (AccessGUDID)]
- Reagent: Yes [EUDAMED]
- Convenience kit: Yes [FDA GUDID (AccessGUDID)]
- Premarket exempt: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains substances of microbial origin: No [EUDAMED]
- IVD kit: No [EUDAMED]
- Self-testing: No [EUDAMED]
- Near-patient testing: No [EUDAMED]
- Professional testing: No [EUDAMED]
- Companion diagnostics: No [EUDAMED]
- IVD instrument: No [EUDAMED]
- New device: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Streck Cell Preservative, Streck. deviCERTS medical device catalogue. https://devicerts.com/devices/streck-cell-preservative-213350 (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/streck-cell-preservative-213350.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/streck-cell-preservative-213350
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.