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MagaBio plus Virus DNA / RNA Purification Kit Ⅱ
EUDAMEDFDA UDIClass A (EU MDR)
Ref BSC71S1BModel BSC71T1S, BSC71S1S, BSC71M1S,BSC71L1S, BSC71T1E,BSC71S1E, BSC71M1E, BSC71L1E, BSC71T1C, BSC71S1C, BSC71S1B, BSC71M1B, BSC71M1E-T, BSC71L1E-T
Identity
- Trade Name
- MagaBio plus Virus DNA / RNA Purification Kit Ⅱ EUDAMEDBIOER MagaBio plus Virus DNA/RNA Purification Kit II FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- MagaBio plus Virus DNA / RNA Purification Kit Ⅱ EUDAMEDFor the detail information, please refer to the IFU. FDA UDI
- Model / Reference
- BSC71T1S, BSC71S1S, BSC71M1S,BSC71L1S, BSC71T1E,BSC71S1E, BSC71M1E, BSC71L1E, BSC71T1C, BSC71S1C, BSC71S1B, BSC71M1B, BSC71M1E-T, BSC71L1E-T EUDAMEDBSC71S1B EUDAMEDFDA UDI
- Description
- For the detail information, please refer to the IFU. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973843226361 EUDAMED06973843228006 FDA UDI
- Basic UDI-DI
- 697384322BSC71HU EUDAMED
- Direct Marketing DI
- 06973843226361 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
- Germany 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
No
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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MagaBio plus Virus DNA / RNA Purification Kit Ⅱ by Hangzhou Bioer Technology Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 697384322BSC71HU | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Bioer Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019512
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 0ecaa3bf-c79b-4b7b-8b3a-6151eba3f509 61 fields · synced May 31, 2026
- FDA UDI fb013353-e017-4879-b310-9555cef1ec4d 33 fields · synced May 30, 2026