Stool Bacterial Pathogens Panel GBSBPP-10

GUDID B178SBPP102

Stool Bacterial Pathogens Panel Cartridge with sample prep device.

GREAT BASIN SCIENTIFIC, INC.

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Primary Device IDB178SBPP102
NIH Device Record Key82b4b316-9472-4019-9182-7f394862ea24
Commercial Distribution StatusIn Commercial Distribution
Brand NameStool Bacterial Pathogens Panel
Version Model NumberGBSBPP-10
Catalog NumberGBSBPP-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
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
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
HIBCCB178GBSBPP100 [Primary]
HIBCCB178SBPP102 [Package]
Contains: B178GBSBPP100
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

PCIGastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay 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 Date2017-07-24

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