FDA.reportPublic FDA data

QIAstat-Dx® Respiratory Panel

Primary DI
04053228033905
Brand
QIAstat-Dx® Respiratory Panel
Company
QIAGEN GmbH
Model
V1
Catalog number
691221
Published
2019-05-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCCRespiratory Virus Panel Nucleic Acid Assay System
OEMHuman Metapneumovirus (Hmpv) Rna Assay System
OEPInfluenza A Virus Subtype Differentiation Nucleic Acid Assay
OOIReal Time Nucleic Acid Amplification System
OOUParainfluenza Multiplex Nucleic Acid Assay
OQW2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
OTGNon-Sars Coronavirus Multiplex Nucleic Acid Assay
OZXMycoplasma Pneumoniae Dna Assay System
OZYChlamydophila Pneumoniae Dna Assay System
OZZBordetella Pertussis Dna Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCCRespiratory Virus Panel Nucleic Acid Assay SystemMicrobiology2
OEMHuman Metapneumovirus (Hmpv) Rna Assay SystemMicrobiology2
OEPInfluenza A Virus Subtype Differentiation Nucleic Acid AssayMicrobiology2
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
OOUParainfluenza Multiplex Nucleic Acid AssayMicrobiology2
OQW2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And IdentificationMicrobiology2
OTGNon-Sars Coronavirus Multiplex Nucleic Acid AssayMicrobiology2
OZXMycoplasma Pneumoniae Dna Assay SystemMicrobiology2
OZYChlamydophila Pneumoniae Dna Assay SystemMicrobiology2
OZZBordetella Pertussis Dna Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183597000QIAstat-Dx Respiratory PanelQIAGEN GmbH2019-05-18OCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053228033905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053228033905040532280339054053228033905

GMDN Terms#

Term, Definition table
TermDefinition
Multiple 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 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-362-7737techservice-na@qiagen.com

Regulatory Flags#

DUNS number
317103745
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053228040576EZ2 Connect MDx900323090032302026-03-03
04053228039402QIAstat-Dx® Respiratory Panel PlusV16912242025-09-25
04053228043850QIAstat-Dx® Meningitis/Encephalitis (ME) PanelV26916212025-10-31
04053228048381QIAstat-Dx® GI Panel 2 Mini BV16914232025-03-28
04053228049166QIAstat-Dx® GI Panel 2 Mini B&VV16914242025-02-18
04053228048862QIAstat-Dx® Respiratory Panel MiniV16912182024-12-05
04053228043249QIAstat-Dx® Gastrointestinal Panel 2V16914212024-06-17
14053228039409QIAstat-Dx® Respiratory Panel PlusV16912242025-09-25
04053228047438QIAstat-Dx® Respiratory Panel PlusV16912242024-06-17
04053228041849QIAstat-Dx® Rise190031632025-09-05
04053228040972CMV Primer ASRV111242602021-06-02
04053228040996CMV Probe ASRV111242642021-06-02
04053228048770QIAcuityDx® Four19110602024-09-30
04053228047582QIAstat-Dx Analyzer 2.0190028282024-09-18
04053228033936QIAstat-Dx® Analyzer 1.0v19002824 2019-05-24
04053228010838Rotor-Gene® Q MDx190020352016-09-24
04053228035725therascreen® BRAF RGQ PCR Kit18748212020-06-11
04053228049418QIAcuityDx® Universal MasterMix Kit1260101 2024-09-30
04053228049432QIAcuityDx® Universal MasterMix Kit12601022024-09-30
04053228034834therascreen® PDGFRA RGQ PCR Kit18749212024-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850028489017MyrnaInflammatix, Inc.OOI2026-04-30
00850028489024TriVerityInflammatix, Inc.OOI2026-04-30
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19DIASORIN MOLECULAR LLCOOI2026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCOOI2026-01-22
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCOOI2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCOOI2026-01-14
30382904452798Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
15420045517486Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517493Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517509Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517516Panther Fusion®Hologic, Inc.OOI2025-10-07
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCOCC2024-07-26
09351179004070EasyScreen™ Gastrointestinal Parasite PCR Positive ControlGENETIC SIGNATURES LIMITEDOOI2024-06-18
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOOU2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOEM2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOZY2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOTG2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOZX2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOCC2024-05-03
00382904439767BD Vaginal Panel on BD COR SystemBECTON, DICKINSON AND COMPANYOOI2024-04-02
00382904452629BD MAX™ CPOBECTON, DICKINSON AND COMPANYOOI2023-10-06
20816101027143Simplexa COVID-19 & Flu A/B DirectDIASORIN MOLECULAR LLCOOI2023-06-23
20816101025835Simplexa Congenital CMV DirectDIASORIN MOLECULAR LLCOOI2023-06-16
20816101025842Simplexa Congenital CMV Positive Control PackDIASORIN MOLECULAR LLCOOI2023-06-16
20816101027150Simplexa COVID-19 & Flu A/B Positive Control Pack DIASORIN MOLECULAR LLCOOI2023-06-16
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOTG2023-05-09
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOCC2023-05-09
20812125010062AcuitasOpgen, Inc.OOI2023-04-28
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOZY2023-04-06
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOOU2023-04-06