# Stool Bacterial Pathogens Panel GBSBPP-10

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/stool-bacterial-pathogens-panel-gbsbpp-10>
- Manufacturer: [Great Basin Scientific, Inc.](https://devicerts.com/manufacturers/great-basin-scientific-inc) (United States, FDA 510(k) applicant)
- Device class: Class II (US FDA)
- FDA product code: PCI, PCH, OOI
- GMDN: Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) (61058)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI B178GBSBPP100 · listed 2017-07-24 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K163571 · issued 2017-07-12 · status: Active

## Recalls

No recall on record.

## Identity

- Trade name: Stool Bacterial Pathogens Panel [FDA GUDID (AccessGUDID)]
- Generic name: Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: GBSBPP-10 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: B178GBSBPP100 [FDA GUDID (AccessGUDID)]
- FDA product code: PCI [FDA GUDID (AccessGUDID)]; PCH [FDA GUDID (AccessGUDID)]; OOI [FDA GUDID (AccessGUDID)]
- GMDN term: Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) (61058) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 866.3990 [FDA GUDID (AccessGUDID)]; 862.2570 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Single use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Stool Bacterial Pathogens Panel GBSBPP-10, Great Basin Scientific, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/stool-bacterial-pathogens-panel-gbsbpp-10 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/stool-bacterial-pathogens-panel-gbsbpp-10.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/stool-bacterial-pathogens-panel-gbsbpp-10
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.