DEVICE: BD MAX™ GBS (00382904417727)
Device Identifier (DI) Information
BD MAX™ GBS
441772
In Commercial Distribution
441772
BECTON, DICKINSON AND COMPANY
441772
In Commercial Distribution
441772
BECTON, DICKINSON AND COMPANY
Kit BD Max GBS
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? |
---|---|---|---|---|
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).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test |
OOI | real time Nucleic acid amplification system |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
46a3eea7-fcae-445e-911b-378fef9123ed
October 24, 2022
3
May 19, 2016
October 24, 2022
3
May 19, 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 |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+1(800)638-8663
Technical_services@bd.com
Technical_services@bd.com