Shiga Toxin Direct Test GBSTEC-10

GUDID B178GBSTEC102

Shiga Toxin Direct Test Cartridge with sample prep device.

GREAT BASIN SCIENTIFIC, INC.

Multiple gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
Primary Device IDB178GBSTEC102
NIH Device Record Key61b9df43-2304-496f-805c-5e01058e9d64
Commercial Distribution StatusIn Commercial Distribution
Brand NameShiga Toxin Direct Test
Version Model NumberGBSTEC-10
Catalog NumberGBSTEC-10
Company DUNS827115259
Company NameGREAT BASIN SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB178GBSTEC100 [Primary]
HIBCCB178GBSTEC102 [Package]
Contains: B178GBSTEC100
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

OOIReal Time Nucleic Acid Amplification System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

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