DEVICE: QIAstat-Dx® Respiratory Panel (04053228033905)
Device Identifier (DI) Information
QIAstat-Dx® Respiratory Panel
V1
Not in Commercial Distribution
691221
QIAGEN GmbH
V1
Not in Commercial Distribution
691221
QIAGEN GmbH
No description.
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. 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 |
FDA Product Code
[?]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 |
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 |
---|
No Device Sizes |
Device Record Status
b06cbff6-fc22-4b51-a491-78d026ff588b
February 06, 2025
4
May 24, 2019
February 06, 2025
4
May 24, 2019
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 |
---|---|
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
[?]
800-362-7737
techservice-na@qiagen.com
techservice-na@qiagen.com