FDA.reportPublic FDA data

QIAcuityDx® Four

Primary DI
04053228048770
Brand
QIAcuityDx® Four
Company
QIAGEN GmbH
Model
1
Catalog number
911060
Device description
The QIAcuityDx® Four is an automated digital PCR (dPCR) instrument designed to perform amplification, detection (qualitative and quantitative), and analysis of nucleic acid samples, isolated from biological specimens. The QIAcuityDx® Four is to be used by trained personnel in a professional laboratory environment.
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
PHGDroplet Digital Pcr System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHGDroplet Digital Pcr SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053228048770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053228048770040532280487704053228048770

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-25 Degrees Celsius60 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
Serial number
true
Manufacturing 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
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
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
03610522040148QXDxBIO-RAD LABORATORIES, INC.PHG2026-08-19
03610522040131QXDxBIO-RAD LABORATORIES, INC.PHG2026-08-14
03610522991303QX600BIO-RAD LABORATORIES, INC.PHG2026-08-14
03610523006433QXDxBIO-RAD LABORATORIES, INC.PHG2026-08-14
04053228049685QIAcuityDx® Nanoplate 26k 24-wellQIAGEN GmbHPHG2024-09-30
06974689624212TARGETINGONETargetingOne Technology (Beijing) CorporationPHG2023-10-20
06974689624229TARGETINGONETargetingOne Technology (Beijing) CorporationPHG2023-10-20
06974689625080TARGETINGONETargetingOne Technology (Beijing) CorporationPHG2023-10-20
06974689625097TARGETINGONETargetingOne Technology (Beijing) CorporationPHG2023-10-20
06974689625103TARGETINGONETargetingOne Technology (Beijing) CorporationPHG2023-10-20
06974689625172TARGETINGONETargetingOne Technology (Beijing) CorporationPHG2023-10-20
06974689625189TARGETINGONETargetingOne Technology (Beijing) CorporationPHG2023-10-20