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Vitros 6801738

by Ortho-Clinical Diagnostics

Vitros 6801738 is a medical device (FDA Class I; FDA product code MSJ, Apolipoproteins) made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 18 Apr 2020 (UDI-DI 10758750006878), 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 Number10758750006878 UDI-DI Date18 Apr 2020ListedStatusListed 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  • Withdrawn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
Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
6801738
Primary DI / UDI-DI
10758750006878
FDA product code
MSJ
GMDN term
Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Device class
Class I
Regulation number
862.1475
GUDID distribution status
In Commercial Distribution

Related devices

Category: Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

Similar devices in this category

Other devices filed under Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry.

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)