AccessGUDID - DEVICE: QIAstat-Dx® Respiratory Panel (04053228033905)

GUDID

Device Identifier (DI) Information

Brand Name: QIAstat-Dx® Respiratory Panel
Version or Model: V1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 691221
Company Name: QIAGEN GmbH

Primary DI Number: 04053228033905
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317103745 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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.

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b06cbff6-fc22-4b51-a491-78d026ff588b
Public Version Date: December 21, 2020
Public Version Number: 3
DI Record Publish Date: May 24, 2019