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Diagnostic BioSystems Mob125R

by Diagnostic BioSystems GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00846405000227 UDI-DIDate8 Jun 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  • Withdrawn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
Hepatitis B virus surface antigen IVD, antibody
Model / Reference
Mob125R
Primary DI / UDI-DI
00846405000227
FDA Product Code
NJT
GMDN Term
Hepatitis B virus surface antigen IVD, antibody
Device Class
Class I
Regulation Number
864.1860
GUDID distribution status
In Commercial Distribution

Other devices from Diagnostic BioSystems

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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