DEVICE: FilmArray® Respiratory Panel 2 (RP2) (00815381020161)
Device Identifier (DI) Information
FilmArray® Respiratory Panel 2 (RP2)
RFIT-ASY-0130
Not in Commercial Distribution
RFIT-ASY-0130
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0130
Not in Commercial Distribution
RFIT-ASY-0130
BIOFIRE DIAGNOSTICS, LLC
IVD reagent kit containing 6 tests
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
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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? |
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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 |
---|---|
OZZ | Bordetella Pertussis Dna Assay System |
OZY | Chlamydophila Pneumoniae Dna Assay System |
OZX | Mycoplasma Pneumoniae Dna Assay System |
OTG | Non-Sars Coronavirus Multiplex Nucleic Acid Assay |
OOU | Parainfluenza Multiplex Nucleic Acid Assay |
OEP | Influenza A Virus Subtype Differentiation Nucleic Acid Assay |
OEM | Human Metapneumovirus (Hmpv) Rna Assay System |
OCC | Respiratory Virus Panel Nucleic Acid Assay System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
274c8e71-d3b2-4bb5-8469-50b7d089d26e
July 28, 2022
5
July 18, 2017
July 28, 2022
5
July 18, 2017
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
[?]
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