EZ1® DSP Virus Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
by Qiagen, Inc.
Identity
- Trade Name
- EZ1 DSP Virus Kit EUDAMEDEZ1® DSP Virus Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- EZ1 DSP Virus Kit EUDAMED
- Model / Reference
- 62724 EUDAMED5 FDA UDI
Identifiers
- Catalog Number
- 62724 FDA UDI
- Primary DI / UDI-DI
- 04053228045809 EUDAMEDFDA UDI
- Basic UDI-DI
- 4053228REZ1VRS000000001G7 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
EZ1® DSP Virus Kit by Qiagen, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Qiagen, Inc.
Sources (2)
- FDA UDI c3b122ab-8c21-48a9-abb6-2e8837b4c961 35 fields · synced Jun 18, 2026
- EUDAMED 22303c71-777c-41f8-b460-8c42716031df 61 fields · synced Jun 18, 2026