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Opi Plus Benzo Level 2 V4 Opi+ Benzo 2 V4 U F Gml

by UTAK Laboratories Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB800OPIBENZO2V4UFGML0 UDI-DI Date26 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Opi Plus Benzo Level 2 V4
Generic Name
Multiple-type clinical chemistry analyte profile IVD, control
Model / Ref / Catalog
OPI+ BENZO 2 V4 U F GML
Primary DI / UDI-DI
B800OPIBENZO2V4UFGML0
FDA Product Code
LAS
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, control
Device Class
Class I
Regulation Number
862.3280
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 3.5 Milliliter

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Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No