DEVICE: JBAIDS (00851458005075)
Device Identifier (DI) Information
JBAIDS
JRPD-ASY-0138
Not in Commercial Distribution
JRPD-ASY-0138
BIOFIRE DEFENSE, LLC
JRPD-ASY-0138
Not in Commercial Distribution
JRPD-ASY-0138
BIOFIRE DEFENSE, LLC
JBAIDS IVD Influenza A Subtyping Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Influenza A virus H5N1 subtype (avian influenza) 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 influenza A virus H5N1 subtype (avian influenza) in a clinical specimen, using a nucleic acid technique (NAT). |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
46c2304c-164e-4825-a52b-54b48cfb20fa
February 12, 2020
4
September 07, 2016
February 12, 2020
4
September 07, 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
[?]
801-262-3592
support@biofiredefense.com
support@biofiredefense.com