Stool Bacterial Pathogens Panel
FDA UDIFDA 510(k)Class II (US FDA UDI)
Identity
- Trade Name
- Stool Bacterial Pathogens Panel FDA UDI
- Generic Name
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Stool Bacterial Pathogens Panel Cartridge with sample prep device. FDA UDI
- Model / Reference
- GBSBPP-10 FDA UDI
- Description
- Stool Bacterial Pathogens Panel Cartridge with sample prep device. FDA UDI
Identifiers
- Catalog Number
- GBSBPP-10 FDA UDI
- Primary DI / UDI-DI
- B178GBSBPP100 FDA UDI
- FDA Product Code
- PCI FDA UDIPCH FDA UDIOOI FDA UDI
- GMDN Term
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3990 FDA UDI862.2570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
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)
Stool Bacterial Pathogens Panel by Great Basin Scientific, Inc. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT).
- PANGEA — Stryker Corp. · Class I
- BD MAX™ Extended Enteric Bacterial Panel — BECTON DICKINSON AND COMPANY · Class II
- BD MAX™ Enteric Bacterial Panel — BECTON DICKINSON AND COMPANY · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163571 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Great Basin Scientific, Inc.
Sources (2)
- FDA UDI 82b4b316-9472-4019-9182-7f394862ea24 60 fields · synced Jun 18, 2026
- FDA 510(k) K163571 1 fields · synced Jun 4, 2026