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Excyte Mini (9mm)

by Elitechgroup Inc.

Excyte Mini (9mm) (EX-10610) is a Class I device made by Elitechgroup Inc., listed in FDA GUDID since 26 Dec 2018 (UDI-DI 03661540304408), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03661540304408 UDI-DI Date26 Dec 2018ListedStatusListed 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  • Withdrawn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
Excyte
Generic name
Erthrocyte sedimentation rate (ESR) analyser IVD
Model / Ref / Catalog
Mini (9mm), EX-10610
Primary DI / UDI-DI
03661540304408
FDA product code
GKB
GMDN term
Erthrocyte sedimentation rate (ESR) analyser IVD
Device class
Class I
Regulation number
864.5800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Erthrocyte sedimentation rate (ESR) analyser IVD

Similar devices

Other devices filed under FDA product code GKB (Device, Automated Sedimentation Rate).

Other devices from Elitechgroup Inc.

See all devices from Elitechgroup Inc. →

Properties

  • Premarket exempt
  • Serial number
Other properties (13, all answered No)