DEVICE: QIAstat-Dx® Respiratory Panel (04053228033905)

Device Identifier (DI) Information

QIAstat-Dx® Respiratory Panel
V1
In Commercial Distribution
691221
QIAGEN GmbH
04053228033905
GS1

1
317103745 *Terms of Use
No description.
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
OZZ Bordetella Pertussis Dna Assay System
OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
OZY Chlamydophila Pneumoniae Dna Assay System
OZX Mycoplasma Pneumoniae Dna Assay System
OTG Non-Sars Coronavirus Multiplex Nucleic Acid Assay
OOI Real Time Nucleic Acid Amplification System
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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

b06cbff6-fc22-4b51-a491-78d026ff588b
December 21, 2020
3
May 24, 2019
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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)

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No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
800-362-7737
techservice-na@qiagen.com
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