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Diagnostic BioSystems C006-NI

by Diagnostic BioSystems GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00846405020133 UDI-DIDate9 Jul 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  • Withdrawn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
Diagnostic BioSystems
Generic Name
Total alkaline phosphatase (ALP) IVD, reagent
Model / Reference
C006-NI
Primary DI / UDI-DI
00846405020133
FDA Product Code
NJT
GMDN Term
Total alkaline phosphatase (ALP) IVD, reagent
Device Class
Class I
Regulation Number
864.1860
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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