FDA.reportPublic FDA data

QIAstat-Dx® Meningitis/Encephalitis (ME) Panel

Primary DI
04053228043850
Brand
QIAstat-Dx® Meningitis/Encephalitis (ME) Panel
Company
QIAGEN GmbH
Model
V2
Catalog number
691621
Device description
IVD kit containing 6 tests
Published
2025-10-31
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
PLOMeningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLOMeningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection SystemMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14053228043857PreviousGS10
04053228043850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1405322804385714053228043857
04053228043850040532280438504053228043850

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type meningitis 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 pathogens associated with meningitis, in a clinical specimen, using a nucleic acid technique (NAT). Pathogens detected may include but are not limited to Streptococcus meningitidis, Neisseria meningitidis, Haemophilus influenzae, adenovirus, enterovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2), varicella-zoster virus (VZV), and Mumps virus.

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
04053228040576EZ2 Connect MDx900323090032302026-03-03
04053228039402QIAstat-Dx® Respiratory Panel PlusV16912242025-09-25
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
04053228033905QIAstat-Dx® Respiratory PanelV16912212019-05-24
04053228034834therascreen® PDGFRA RGQ PCR Kit18749212024-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20816101025774Simplexa™ VZV DirectDIASORIN MOLECULAR LLCPLO2019-06-19
20816101025781Simplexa™ VZV Positive Control PackDIASORIN MOLECULAR LLCPLO2019-06-19
00815381020123FilmArray® Meningitis/Encephalitis (ME) PanelBIOFIRE DIAGNOSTICS, LLCPLO2016-09-23
00815381020130FilmArray® Meningitis/Encephalitis (ME) PanelBIOFIRE DIAGNOSTICS, LLCPLO2016-09-23