Identity
- Trade Name
- EZ1 DSP DNA Blood Kit EUDAMEDEZ1® DSP DNA Blood Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- EZ1 DSP DNA Blood Kit EUDAMED
- Model / Reference
- 62124 EUDAMED4 FDA UDI
Identifiers
- Catalog Number
- 62124 FDA UDI
- Primary DI / UDI-DI
- 04053228045816 EUDAMEDFDA UDI
- Basic UDI-DI
- 4053228REZ1BOD0000000018G 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
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
No
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
EZ1 DSP DNA Blood Kit 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 | 4053228REZ1BOD0000000018G | 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 954c3ffe-fe74-440c-81b2-935168f08ed6 61 fields · synced Jul 10, 2026
- FDA UDI 3ba7615e-bc79-4acc-b23f-427fbb619cab 35 fields · synced May 30, 2026