QIAamp DSP DNA FFPE Tissue Kit
EUDAMEDFDA UDIClass A (EU MDR)
by QIAGEN GmbH
Identity
- Trade Name
- QIAamp DSP DNA FFPE Tissue Kit EUDAMEDQIAamp® DSP DNA FFPE Tissue Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- QIAamp DSP DNA FFPE Tissue Kit EUDAMED
- Model / Reference
- 60404 EUDAMED2 FDA UDI
Identifiers
- Catalog Number
- 60404 FDA UDI
- Primary DI / UDI-DI
- 04053228045861 EUDAMEDFDA UDI
- Basic UDI-DI
- 4053228RQAFFPE000000001QM EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Nucleic acid extraction/isolation kit IVD
QIAamp DSP DNA FFPE Tissue Kit by QIAGEN GmbH — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4053228RQAFFPE000000001QM | 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 8e0d102e-28bb-4309-b6ac-325d3dd89841 61 fields · synced Jun 8, 2026
- FDA UDI ffdabc55-0d42-456b-b6de-a790a3d7d216 35 fields · synced May 30, 2026