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QIAsymphony DSP Circulating DNA Maxi Kit (192)
EUDAMEDFDA UDIClass A (EU MDR)
Ref 937566
by QIAGEN GmbH
Identity
- Trade Name
- QIAsymphony DSP Circulating DNA Maxi Kit (192) EUDAMEDQIAsymphony® DSP Circulating DNA Maxi Kit (192) FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- QIAsymphony DSP Circulating DNA Kit EUDAMED
- Model / Reference
- 937566 EUDAMED1 FDA UDI
Identifiers
- Catalog Number
- 937566 FDA UDI
- Primary DI / UDI-DI
- 04053228048268 EUDAMEDFDA UDI
- Basic UDI-DI
- 4053228RQSCDNA00000000157 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
QIAsymphony DSP Circulating DNA Maxi Kit (192) by QIAGEN GmbH — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4053228RQSCDNA00000000157 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- QIAGEN GmbH
- EUDAMED SRN
- DE-MF-000004949
Sources (2)
- EUDAMED 1fb3d2e2-637f-4a0c-83b6-b9f737f89c44 61 fields · synced Jun 18, 2026
- FDA UDI 988e8f63-631c-4ed6-9309-b6a37ad69841 35 fields · synced May 30, 2026