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Ortho 6842222

by Ortho-Clinical Diagnostics

Ortho 6842222 is a Class II device made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 7 Apr 2021 (UDI-DI 10758750032846), 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 Number10758750032846 UDI-DI Date7 Apr 2021ListedStatusListed 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  • Withdrawn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
Ortho
Generic name
Agglutination assay digital imaging reader/analyser IVD
Model / Ref / Catalog
6842222
Primary DI / UDI-DI
10758750032846
FDA product code
KSZ
GMDN term
Agglutination assay digital imaging reader/analyser IVD
Device class
Class II
Regulation number
864.9175
GUDID distribution status
In Commercial Distribution

Related devices

Category: Agglutination assay digital imaging reader/analyser IVD

Similar devices

Other devices filed under FDA product code KSZ (SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY).

Other devices from Ortho-Clinical Diagnostics

See all devices from Ortho-Clinical Diagnostics →

Properties

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