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Ortho 936396

by Ortho-Clinical Diagnostics

Ortho 936396 is a device classified as Not classified made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 24 Aug 2016 (UDI-DI 10758750005451), 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 Number10758750005451 UDI-DI Date24 Aug 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  • Withdrawn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
Ortho
Generic name
Enzyme immunoassay (EIA) analyser IVD
Model / Ref / Catalog
936396
Primary DI / UDI-DI
10758750005451
FDA product code
MZA
GMDN term
Enzyme immunoassay (EIA) analyser IVD
Device class
N
GUDID distribution status
In Commercial Distribution

Related devices

Category: Enzyme immunoassay (EIA) analyser IVD

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)