DEVICE: Staph ID/R Blood Culture Panel (B178GBSIDR100)
Device Identifier (DI) Information
Staph ID/R Blood Culture Panel
GBSIDR-10
In Commercial Distribution
GBSIDR-10
GREAT BASIN SCIENTIFIC, INC.
GBSIDR-10
In Commercial Distribution
GBSIDR-10
GREAT BASIN SCIENTIFIC, INC.
No description.
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? |
|---|---|---|---|---|
| 60864 | MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT) |
A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique (NAT).
|
Active | false |
| 51697 | MRSE nucleic acid detection 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 conferring methicillin resistance, in methicillin-resistant Staphylococcus epidermidis (MRSE) bacteria present in a clinical specimen using a nucleic acid technique (NAT).
|
Active | false |
| 51656 | Multiple Staphylococcus bacterial species culture isolate identification IVD, kit |
A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of Staphylococcus bacteria or other similar gram positive, catalase positive cocci isolated by culture from a clinical specimen.
|
Active | false |
| 51667 | MRSA 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 conferring methicillin resistance, in methicillin-resistant Staphylococcus aureus (MRSA) bacteria present in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT).
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| OOI | Real Time Nucleic Acid Amplification System |
| PAM | Gram-Positive Bacteria And Their Resistance Markers |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
44f2789a-d3ac-42f9-b8b8-8301106e4e3c
January 23, 2019
3
September 23, 2016
January 23, 2019
3
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 |
|---|---|---|---|---|---|
| B178GBSIDR102 | 10 | B178GBSIDR100 | In Commercial Distribution | Box |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| 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