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On Call® Sure Ketone Control Solution Ogc-511

by Acon 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00682607815272 UDI-DI Date30 Jul 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  • Withdrawn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
On Call® Sure Ketone Control Solution
Generic Name
Ketone (acetoacetate) IVD, control
Model / Ref / Catalog
OGC-511, GK125-221-101
Description
2mL Control Solution 0 (1), 2mL Control Solution 1 (1), 2mL Control Solution 2 (1), Package Insert (1)
Primary DI / UDI-DI
00682607815272
FDA Product Code
NBW, JIN
GMDN Term
Ketone (acetoacetate) IVD, control
Device Class
Class II
Regulation Number
862.1345, 862.1435
GUDID distribution status
In Commercial Distribution

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Properties

  • Over-the-Counter
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No