PCL Covid 19 Ag Gold Self Test Kit
Intended Use
In vitro diagnostic medical device applying sandwich fluorescent immunoassay to qualitatively detect N protein (nucleocapsid protein) of SARS-CoV-2 antigen in human saliva and nasopharyngeal specimens.
Kit Components
| 100 Test / Kit | 50 Test / Kit | 5 Test / Kit | 1 Test / Kit | |
|---|---|---|---|---|
| Test Card | 100 ea | 50 ea | 5 ea | 1 ea |
| Diluent Tube | 8 bottles to aliquot |
50 ea | 5 ea | 1 ea |
| Filter Cap | 100 ea | 50 ea | 5 ea | 1 ea |
| IFU | 1 ea | 1 ea | 1 ea | 1 ea |
Certificate & Record
- CE-IVD
- MFDS FSC
- Austria
- Germany BfArM
- Italy ISS
- India ICMR Validation
- Serbia
- Montenegro
- Bosnia Hercegovina
- Guatemala
- Peru
- Indonesia Process