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Calibrator, Level 2 BK-465909D

by DIAMOND DIAGNOSTICS Inc

Calibrator, Level 2 BK-465909D is a Class II device made by DIAMOND DIAGNOSTICS Inc, listed in FDA GUDID since 5 Jun 2023 (UDI-DI 00811403011568), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00811403011568 UDI-DI Date5 Jun 2023ListedStatusListed 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  • Withdrawn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
Calibrator, Level 2
Generic name
Multiple electrolyte IVD, calibrator
Model / reference
BK-465909D
Primary DI / UDI-DI
00811403011568
FDA product code
JIT
GMDN term
Multiple electrolyte IVD, calibrator
Device class
Class II
Regulation number
862.1150
GUDID distribution status
In Commercial Distribution

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Properties

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