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Vitros 6801698

by Ortho-Clinical Diagnostics

Vitros 6801698 is a Class II device made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 23 Aug 2016 (UDI-DI 10758750006625), 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 Number10758750006625 UDI-DI Date23 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  • Withdrawn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
Vitros
Generic name
Gentamicin therapeutic drug monitoring IVD, calibrator
Model / Ref / Catalog
6801698
Primary DI / UDI-DI
10758750006625
FDA product code
DLJ
GMDN term
Gentamicin therapeutic drug monitoring IVD, calibrator
Device class
Class II
Regulation number
862.3200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gentamicin therapeutic drug monitoring IVD, calibrator

Other devices from Ortho-Clinical Diagnostics

See all devices from Ortho-Clinical Diagnostics →

Properties

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