MagaBio plus Virus RNA Purification Kit Ⅱ
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- MagaBio plus Virus RNA Purification Kit Ⅱ EUDAMEDBIOER MagaBio plus Virus RNA Purification Kit II FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- MagaBio plus Virus RNA Purification Kit Ⅱ EUDAMEDFor the detail information, please refer to the IFU. FDA UDI
- Model / Reference
- BSC87T1S, BSC87S1S, BSC87M1S, BSC87N1E, BSC87T1E, BSC87S1E, BSC87M1E, BSC87L1E, BSC87S1B, BSC87M1B, BSC87M1E-T, BSC87L1E-T, BSC87T1P, BSC87S1P EUDAMEDBSC87S1E EUDAMEDFDA UDI
- Description
- For the detail information, please refer to the IFU. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973843227641 EUDAMED06973843228549 FDA UDI
- Basic UDI-DI
- 697384322BSC87JB EUDAMED
- Direct Marketing DI
- 06973843227641 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
No
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Category: Nucleic acid extraction/isolation kit IVD
MagaBio plus Virus RNA Purification Kit Ⅱ by Hangzhou Bioer Technology Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
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- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697384322BSC87JB | 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 006fcff4-870d-4d6a-a58c-0bddcbf3c422 61 fields · synced Jul 25, 2026
- FDA UDI 8d8661cd-6b5f-41da-aed5-76dd328e0faa 33 fields · synced May 30, 2026