Skip to content

hemochroma PLUS Analyzer 100-101

by Immunostics

hemochroma PLUS Analyzer 100-101 is a Class II device made by Immunostics, listed in FDA GUDID since 20 Dec 2018 (UDI-DI 10722355003013), registry data as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10722355003013 UDI-DI Date20 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  • Withdrawn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
hemochroma PLUS Analyzer
Generic name
Total haemoglobin (totHb) IVD, kit, spectrophotometry
Model / Ref / Catalog
100-101
Primary DI / UDI-DI
10722355003013
FDA product code
GKR
GMDN term
Total haemoglobin (totHb) IVD, kit, spectrophotometry
Device class
Class II
Regulation number
864.5620
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total haemoglobin (totHb) IVD, kit, spectrophotometry

Similar devices

Other devices filed under FDA product code GKR (SYSTEM, HEMOGLOBIN, AUTOMATED).

Other devices from Immunostics

See all devices from Immunostics →

Properties

  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)