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Ethanol 76 Mg/Dl Eth 76 Wb F Osbi

by UTAK Laboratories Inc. GUDID 2 variants

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB800ETH76WBFOSBI0 UDI-DIDate23 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Ethanol 76 Mg/Dl
Generic Name
Multiple-type clinical chemistry analyte profile IVD, control
Model / Ref / Catalog
ETH 76 WB F OSBI
Primary DI / UDI-DI
B800ETH76WBFOSBI0
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 — 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