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BD MAX™ Enteric Parasite Panel (US/CAN) 443380

by Geneohm Sciences Canada Inc

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number00382904433802 UDI-DIDate19 May 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2329-2019 FDA Class II initiated 17 Jul 2019

    The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
BD MAX™ Enteric Parasite Panel (US/CAN)
Generic Name
Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
443380
Primary DI / UDI-DI
00382904433802
510(k) Number
FDA Product Code
PCH, OOI
GMDN Term
Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Device Class
Class II
Regulation Number
866.3990, 862.2570
GUDID distribution status
Not in Commercial Distribution

Other devices from Geneohm Sciences Canada Inc

Properties

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

Other properties (10)

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