DEVICE: Stool Bacterial Pathogens Panel (B178GBSBPP100)

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Device Record History
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Device Identifier (DI) Information
Stool Bacterial Pathogens Panel
GBSBPP-10
In Commercial Distribution
GBSBPP-10
GREAT BASIN SCIENTIFIC, INC.
B178GBSBPP100
HIBCC

1
827115259 *Terms of Use
Stool Bacterial Pathogens Panel Cartridge with sample prep device.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61058 Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.
Active false
59859 Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen, using a microarray method. Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.
Active false
47381 Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple bacteria genera associated with gastrointestinal diseases, in a clinical specimen, using a nucleic acid technique (NAT). Bacteria detected may include Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Bacillus and/or Vibrio species.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
OOI Real Time Nucleic Acid Amplification System
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
82b4b316-9472-4019-9182-7f394862ea24
December 18, 2023
4
July 24, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B178SBPP102 10 B178GBSBPP100 In Commercial Distribution Box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
(888) 333-9763
customersupport@gbscience.com
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