Identity
- Trade Name
- Shiga Toxin Direct Test FDA UDI
- Generic Name
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray FDA UDI
- Device Name
- Shiga Toxin Direct Test Cartridge with sample prep device. FDA UDI
- Model / Reference
- GBSTEC-10 FDA UDI
- Description
- Shiga Toxin Direct Test Cartridge with sample prep device. FDA UDI
Identifiers
- Catalog Number
- GBSTEC-10 FDA UDI
- Primary DI / UDI-DI
- B178GBSTEC100 FDA UDI
- FDA Product Code
- OOI FDA UDIPCH FDA UDI
- GMDN Term
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 FDA UDI866.3990 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
Shiga Toxin Direct Test by Great Basin Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray.
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- Enteric Pathogens (EP) Stool Sample Preparation Kit — Luminex Corporation · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Great Basin Scientific, Inc.
Sources (1)
- FDA UDI 61b9df43-2304-496f-805c-5e01058e9d64 36 fields · synced Jun 6, 2026