QIAstat-Dx® Rise
FDA UDIEUDAMEDClass II (US FDA UDI)
by Qiagen, Inc.
Identity
- Trade Name
- QIAstat-Dx Rise EUDAMEDQIAstat-Dx® Rise FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- QIAstat-Dx Rise EUDAMEDThe QIAstat-Dx Rise system is intended as an in-vitro diagnostic device for use with QIAstat-Dx in-vitro diagnostic assays indicated for use with QIAstat-Dx Rise and provides full automation from sample preparation to real-time PCR detection for molecular applications. The system is designed for professional use only and it is not a device for self-testing or near-patient testing. FDA UDI
- Model / Reference
- 9003163 EUDAMED1 FDA UDI
- Description
- The QIAstat-Dx Rise system is intended as an in-vitro diagnostic device for use with QIAstat-Dx in-vitro diagnostic assays indicated for use with QIAstat-Dx Rise and provides full automation from sample preparation to real-time PCR detection for molecular applications. The system is designed for professional use only and it is not a device for self-testing or near-patient testing. FDA UDI
Identifiers
- Catalog Number
- 9003163 FDA UDI
- Primary DI / UDI-DI
- 04053228041849 EUDAMEDFDA UDI
- Basic UDI-DI
- 4053228IQSTAR0000000001VV EUDAMED
- Direct Marketing DI
- 04053228041849 EUDAMED
- FDA Product Code
- OOI FDA UDI
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory
QIAstat-Dx® Rise by Qiagen, Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Qiagen, Inc.
Sources (2)
- FDA UDI 1ae972a4-fa3b-4fa3-b4df-1b41d0a665a4 36 fields · synced Jul 12, 2026
- EUDAMED 0139b0d8-3ba1-4394-880e-1811df7d11a5 61 fields · synced Jul 12, 2026