Eu Ivdr
Eu Ivd Class A
On The Market
π¨π³ China
Nucleic Acid Analysis Device
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06955792730489
- Basic UDI-DI Code
- 69557927SQ35C0000001ML
- Reference
- S-Q35C
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Sansure Biotech Inc.
Additional Description
The Nucleic Acid Analysis Device (S-Q35C) adopts constant temperature amplification technology and is used together with supporting detection reagents for qualitative detection of nucleic acid. The applicable items are mainly respiratory infectious disease detection and sexually transmitted disease detection. The results can be used to assist diagnosis and provide molecular diagnostic basis for infected patients and should not be used as the sole basis for patient management decisions. Applicable sample type: nasal swab, throat swab. 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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