DEVICE: BD MAX™ Enteric Bacterial Panel (US/CAN) (00382904433789)
Device Identifier (DI) Information
BD MAX™ Enteric Bacterial Panel (US/CAN)
443378
In Commercial Distribution
443378
Geneohm Sciences Canada Inc
443378
In Commercial Distribution
443378
Geneohm Sciences Canada Inc
BD MAX™ Enteric Bacterial Panel (US/CAN)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Multiple 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 one or more bacteria 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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PCH | Gastrointestinal pathogen panel multiplex nucleic acid-based assay system |
PCI | Gastrointestinal bacterial panel multiplex nucleic acid-based assay system |
OOI | real time Nucleic acid amplification system |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K140111 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
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
d419b0ef-de37-40ba-86ce-f324d7f7dad3
July 06, 2018
3
July 27, 2016
July 06, 2018
3
July 27, 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 |
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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
[?]
+1(800)638-8663
Technical_services@bd.com
Technical_services@bd.com