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HighPrep Viral DNA & RNA Kit - DX (384 preps)
EUDAMEDFDA UDIClass A (EU MDR)
Ref HPV-DR96x4EModel Kit for viral RNA and DNA isolation
Identity
- Trade Name
- HighPrep Viral DNA & RNA Kit - DX (384 preps) EUDAMEDMagBio Genomics, Inc. FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- HighPrep Viral DNA & RNA Kit - DX (384 preps) EUDAMEDViral RNA and DNA isolation FDA UDI
- Model / Reference
- Kit for viral RNA and DNA isolation EUDAMEDHPV-DR96x4E EUDAMEDHighPrep™ Viral DNA/RNA FDA UDI
- Description
- Viral RNA and DNA isolation FDA UDI
Identifiers
- Catalog Number
- HPV-DR96x4 FDA UDI
- Primary DI / UDI-DI
- 00850045030070 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850045030HPV-DR96x4E5N EUDAMED
- Direct Marketing DI
- 00850045030070 EUDAMED
- 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 EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
HighPrep Viral DNA & RNA Kit - DX (384 preps) by MagBio Genomics, Inc. — 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 | 0850045030HPV-DR96x4E5N | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- MagBio Genomics, Inc.
- EUDAMED SRN
- US-MF-000038221
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 5fd6a974-82da-4543-beca-1252ff038566 61 fields · synced Jul 9, 2026
- FDA UDI f7f6ab04-0463-4f9d-8bee-5980d931d4cf 35 fields · synced May 26, 2026