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ESR-Chex 214108

by Streck

ESR-Chex 214108 is a Class I device made by Streck, listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00844509001645), 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 Number00844509001645 UDI-DI Date19 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  • Withdrawn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
ESR-Chex
Generic name
Erythrocyte sedimentation rate (ESR) IVD, control
Model / Ref / Catalog
214108
Description
A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 4 vials each of level 1 & 2.
Primary DI / UDI-DI
00844509001645
FDA product code
JPH
GMDN term
Erythrocyte sedimentation rate (ESR) IVD, control
Device class
Class I
Regulation number
864.6700
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 9.0 Milliliter

Related devices

Category: Erythrocyte sedimentation rate (ESR) IVD, control

Similar devices in this category

Other devices filed under Erythrocyte sedimentation rate (ESR) IVD, control.

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Properties

  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)