FDA.reportPublic FDA data

QIAstat-Dx® Respiratory Panel Mini

Primary DI
04053228048862
Brand
QIAstat-Dx® Respiratory Panel Mini
Company
QIAGEN GmbH
Model
V1
Catalog number
691218
Device description
IVD kit containing 6 tests
Published
2024-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14053228048869PackageGS16In Commercial Distribution
04053228048862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1405322804886914053228048869
04053228048862040532280488624053228048862

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room temperature
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317103745
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053228049982QIAsymphony® Connect190034502026-07-28
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
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
04053228033905QIAstat-Dx® Respiratory PanelV16912212019-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332940010089Xpert®CEPHEIDQOF2026-10-29
07332940009267Xpert®CEPHEIDQOF2026-10-08
00819704020685FINDERBaebies, Inc.QOF2026-10-01
00850025770019Fast PCR Mini Respiratory Panel Test DiscAutonomous Medical Devices IncorporatedQOF2026-08-26
00850025770088Fast PCR Mini Respiratory Panel Test Disc and Accessory Kits (qty 20)Autonomous Medical Devices IncorporatedQOF2026-08-26
00850025770156Fast PCR Mini Respiratory Panel Test Disc and Accessory Kits (qty 10)Autonomous Medical Devices IncorporatedQOF2026-08-26
00819704020074FINDER InstrumentBaebies, Inc.QOF2026-05-01
00819704020425FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.QOF2026-05-01
00819704020463FINDER Cleaning AccessoryBaebies, Inc.QOF2026-05-01
00819704020487FINDER RVP BufferBaebies, Inc.QOF2026-05-01
00819704020630FINDER Flu A&B/SARS-CoV-2 Positive Control SwabBaebies, Inc.QOF2026-05-01
00819704020654FINDER Flu A&B/SARS-CoV-2 Negative Control SwabBaebies, Inc.QOF2026-05-01
05061098480025NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
05061098480032NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
00875197006377cobas® SARS-CoV-2 & Influenza A/B Quality Control KitRoche Molecular Systems, Inc.QOF2026-02-24
00875197007329cobas® Respiratory flex Control KitRoche Molecular Systems, Inc.QOF2026-02-24
00875197007541cobas® Respiratory 4-flexRoche Molecular Systems, Inc.QOF2026-02-24
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19DIASORIN MOLECULAR LLCQOF2026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCQOF2026-01-22
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCQOF2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCQOF2026-01-14
04053228039402QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
14053228039409QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
00884999049369Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00884999049376Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00884999049383Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00875197006285cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testRoche Molecular Systems, Inc.QOF2025-05-28
00875197007299cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testRoche Molecular Systems, Inc.QOF2025-05-28
00875197007305cobas liat SARS-CoV-2, Influenza A/B & RSV control kitRoche Molecular Systems, Inc.QOF2025-05-28
00810031720019Visby Medical Respiratory Health Visby Medical, Inc.QOF2025-03-19