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Stool Bacterial Pathogens Panel GBSBPP-10

by Great Basin Scientific, Inc.

Stool Bacterial Pathogens Panel GBSBPP-10 is a medical device (FDA Class II) made by Great Basin Scientific, Inc., cleared under FDA 510(k) K163571 on 12 Jul 2017 and listed in FDA GUDID since 24 Jul 2017 (UDI-DI B178GBSBPP100), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberB178GBSBPP100 UDI-DI Date24 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK163571 Date12 Jul 2017IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K163571 decided 12 Jul 2017 Active
  • FDA GUDID UDI-DI B178GBSBPP100 listed 24 Jul 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K163571
  2. Listed FDA GUDID B178GBSBPP100

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Trade name
Stool Bacterial Pathogens Panel
Generic name
Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
GBSBPP-10
Primary DI / UDI-DI
B178GBSBPP100
FDA product code
PCI, 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
In Commercial Distribution

Related devices

Category: Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarrayMultiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

Similar devices

Other devices filed under FDA product code PCH.

Other devices from Great Basin Scientific, Inc.

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)