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CD-Chex Plus 213340

by Streck

CD-Chex Plus 213340 is a Class II device made by Streck, listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00844509000105), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00844509000105 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
CD-Chex Plus
Generic name
Multiple CD cell marker IVD, control
Model / Ref / Catalog
213340
Description
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial each of levels CD4L and Normal.
Primary DI / UDI-DI
00844509000105
FDA product code
GGL
GMDN term
Multiple CD cell marker IVD, control
Device class
Class II
Regulation number
864.8625
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 2.5 Milliliter

Related devices

Category: Multiple CD cell marker IVD, control

Similar devices

Other devices filed under FDA product code GGL (Control, White-Cell).

Other devices from Streck

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Properties

  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)