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Vitros 1988211

by Ortho-Clinical Diagnostics

Vitros 1988211 is a Class II device made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 23 Aug 2016 (UDI-DI 10758750000388), 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 Number10758750000388 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  • Withdrawn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
Albumin IVD, reagent
Model / Ref / Catalog
1988211
Primary DI / UDI-DI
10758750000388
FDA product code
CIX
GMDN term
Albumin IVD, reagent
Device class
Class II
Regulation number
862.1035
GUDID distribution status
In Commercial Distribution

Related devices

Category: Albumin IVD, reagent

Similar devices in this category

Other devices filed under Albumin IVD, reagent.

Other devices from Ortho-Clinical Diagnostics

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Properties

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