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Bd Max™ Rna-3 437506

by Geneohm Sciences Canada Inc

Listed FDA GUDID listing, not in commercial distribution

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 Number00382904375065 UDI-DIDate25 May 2018ListedStatusListed GUDID: not 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  • Withdrawn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
Bd Max™ Rna-3
Generic Name
Nucleic acid extraction/isolation kit IVD
Model / Ref / Catalog
437506
Primary DI / UDI-DI
00382904375065
FDA Product Code
JJH
GMDN Term
Nucleic acid extraction/isolation kit IVD
Device Class
Class I
Regulation Number
862.2310
GUDID distribution status
Not in Commercial Distribution

Other devices from Geneohm Sciences Canada Inc

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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