DEVICE: Group B Strep Assay (B178GBGBS100)
Device Identifier (DI) Information
Group B Strep Assay
GBGBS-10
In Commercial Distribution
GBGBS-10
GREAT BASIN SCIENTIFIC, INC.
GBGBS-10
In Commercial Distribution
GBGBS-10
GREAT BASIN SCIENTIFIC, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
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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? |
---|---|---|---|---|
51753 | Beta-haemolytic Group B Streptococcus 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 Group B beta-haemolytic Streptococcus bacteria in a clinical specimen, using a nucleic acid technique (NAT).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OOI | Real Time Nucleic Acid Amplification System |
NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
11703581-5ef4-4b63-adf1-78b8b914c66c
March 29, 2018
2
September 23, 2016
March 29, 2018
2
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B178GBGBS102 | 10 | B178GBGBS100 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(888) 333-9763
customersupport@gbscience.com
customersupport@gbscience.com