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Isavuconazole Plus Calibrator 1 V2 Isa+ Cal 1 V2 S F Ucsf

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 NumberB800ISACAL1V2SFUCSF0 UDI-DI Date7 Oct 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  • Withdrawn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
Isavuconazole Plus Calibrator 1 V2
Generic Name
Multiple-therapy therapeutic drug monitoring IVD, control
Model / Ref / Catalog
ISA+ CAL 1 V2 S F UCSF
Primary DI / UDI-DI
B800ISACAL1V2SFUCSF0
FDA Product Code
LAS
GMDN Term
Multiple-therapy therapeutic drug monitoring IVD, control
Device Class
Class I
Regulation Number
862.3280
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1 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