FDA.reportPublic FDA data

QIAcuityDx® Universal MasterMix Kit

Primary DI
04053228049418
Brand
QIAcuityDx® Universal MasterMix Kit
Company
QIAGEN GmbH
Model
1
Catalog number
260101
Device description
The QIAcuityDx® Universal MasterMix Kit is a ready-to-use general purpose dPCR MasterMix reagent set for use with the QIAcuityDx® Four in conjunction with associated assay specific reagents as part of validated diagnostic test procedures.The QIAcuityDx® Universal MasterMix Kit is intended for in vitro diagnostic use.The QIAcuityDx® Universal MasterMix Kit is not an automated device and is intended for laboratory use by trained personnel.It is the user’s responsibility to validate system performance for any procedures used in their laboratory which are not covered by the QIAGEN performance studies.
Published
2024-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053228049418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053228049418040532280494184053228049418

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid amplification mastermix kit IVDA collection of reagents and other associated materials intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)} in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a constant temperature freezer. Protect from light.
Storage Environment Temperature-30 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8003627737techservice-na@qiagen.com

Regulatory Flags#

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

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04053228040576EZ2 Connect MDx900323090032302026-03-03
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04053228047438QIAstat-Dx® Respiratory Panel PlusV16912242024-06-17
04053228041849QIAstat-Dx® Rise190031632025-09-05
04053228040972CMV Primer ASRV111242602021-06-02
04053228040996CMV Probe ASRV111242642021-06-02
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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
04053228049432QIAcuityDx® Universal MasterMix Kit12601022024-09-30
04053228033905QIAstat-Dx® Respiratory PanelV16912212019-05-24
04053228034834therascreen® PDGFRA RGQ PCR Kit18749212024-12-10

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05407010129281NTT-001-L Buffer - 200L bagLonza VerviersPPM2025-10-30
05407010129298NTT-001-L Buffer - 500L bagLonza VerviersPPM2025-10-30
05407010129304NTT-001-K : 1M NaCl - 1L bag SAMPLELonza VerviersPPM2025-10-30
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