VIROLOGY - RT & POC - OTHER
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Basic Information
- Primary DI
- 06975445472030
- Basic UDI-DI Code
- B-06975445472030
- Reference
- 2019-nCoV IgM/IgG Antibody (whole blood/serum/plasma) Detection Kit
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- FARMASINO MEDICAL CO., LTD
Additional Description
This product is used to qualitatively detect 2019-nCoV IgM/lgG antibody in human serum and plasma. In view of the methodological characteristics of antibody detection reagents,the product is only used as a supplementary detection indicator for suspected cases of negative detection of nucleic acid or used in conjunction with nucleic acid detection in the diagnosis of suspected cases,and is not used as a basis for the diagnosis and elimination of pneumonia caused by novel coronavirus infection. It‘s not suitbale for general population screening.For medical institutions only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Similar Devices
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