DEVICE: BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (00815381020765)
Device Identifier (DI) Information
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
424589
In Commercial Distribution
BIOFIRE DIAGNOSTICS, LLC
424589
In Commercial Distribution
BIOFIRE DIAGNOSTICS, LLC
IVD reagent kit containing 30 tests.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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61527 | Multiple-type respiratory pathogen 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 multiple types of microorganisms (bacteria, fungi and/or viruses) associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, influenza A, respiratory syncytial viruses A and B, rhinovirus, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, and/or enterovirus.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents |
OCC | Respiratory Virus Panel Nucleic Acid Assay System |
OTG | Non-Sars Coronavirus Multiplex Nucleic Acid Assay |
OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K230719 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bc1f446d-3d22-445d-b70e-aa4aa2ba6d0e
May 17, 2023
1
May 09, 2023
May 17, 2023
1
May 09, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined