Eu Ivdr
Eu Ivd Class A
On The Market
π¨π³ China
Portable Molecule Workstation
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06955792731301
- Basic UDI-DI Code
- 69557927SQ31A0000001HJ
- Reference
- S-Q31A
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Sansure Biotech Inc.
Additional Description
The Portable Molecule Workstation (iPonatic) is used in conjunction with the related reagent manufactured by Sansure Biotech Inc. Based on polymerase chain reaction (PCR) technology, this iPonatic can be used for clinical extraction, amplification and analysis of the nucleic acids (DNA/RNA) existed in the samples from the human body. For in vitro diagnostic use only. For professional use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02050116 | NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS |
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