DEVICE: FilmArray® Respiratory Panel (RP) EZ (00815381020147)

Device Identifier (DI) Information

FilmArray® Respiratory Panel (RP) EZ
RFIT-ASY-0120
Not in Commercial Distribution
RFIT-ASY-0120
BIOFIRE DIAGNOSTICS, LLC
00815381020147
GS1
December 08, 2021
1
079280262 *Terms of Use
IVD reagent kit containing 30 tests.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OZX Mycoplasma Pneumoniae Dna Assay System
OZY Chlamydophila Pneumoniae Dna Assay System
OZZ Bordetella Pertussis Dna Assay System
OOI Real Time Nucleic Acid Amplification System
OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
OTG Non-Sars Coronavirus Multiplex Nucleic Acid Assay
OEP Influenza A Virus Subtype Differentiation Nucleic Acid Assay
OOU Parainfluenza Multiplex Nucleic Acid Assay
OEM Human Metapneumovirus (Hmpv) Rna Assay System
OCC Respiratory Virus Panel Nucleic Acid Assay System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152579 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

61e67b33-a151-409a-a818-5d9b00fcfed9
May 03, 2022
6
December 06, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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