BNIBT
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Basic Information
- Primary DI
- 06975456580212
- Basic UDI-DI Code
- B-06975456580212
- Reference
- 10005844
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Beijing North Institute of Biotechnology Co.,Ltd.
Additional Description
The reagent utilizes the principle of colloidal gold immunochromatography. When an appropriate amount of the test sample is added into the sample hole of the test cassette, the sample will be move forward along the test cassette under the action of capillary. If the sample contains covid-19 antigen, the antigen will bind to the colloidal gold-labeled COVID-19 antibody. The immune complex forms a sandwich complex with another coated COVID-19 antibody at the detection line (T line), showing that the COVID-19 antigen is positive.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-224/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Similar Devices
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