Ann: Test Platform and COVID-19 Test receive CE Mark approval, page-924

just checking the European Commission page on diagnostic devices and found that our page was updated on 8/7/2021. can't see the reason for the update, still says specimen nasopharyngeal swab. checked other tests and the 10 or so I checked, none were updated on the same day?  

I did notice that under format we had manual, near POC/POC. a lot of other tests only had near POC/POC.

maybe clutching at straws, probably am, but could the manual be the update on our saliva submission seeing that " CE regulatory submission will be made to amend the instruction for use (IFU) of the current EuGeni SARS-CoV-@ ART to include oral saliva sampling."

anyway will be watching for an ann tomorrow. if I am off track, I have never seen this posted before...


COVID-19 In Vitro Diagnostic Medical Device - detail
SARS-CoV-2 Ag RDT
Manufactured by AnteoTech Ltd, Australia - https://www.anteotech.com
Device identification number
2376
CE Marking ✓Yes
HSC common list.  ×No
HSC mutual recognition   ×No
Format Manual, Near POC / POC
Physical Support.  Cassette, Lateral flow
Target.   Antigen
Specimen.  Nasopharyngeal swab
Pathogens detected.  SARS-CoV
Commercial Status.  Commercialised
Last Update.  2021-07-08 10:52:02 CET
Comments
The SARS-CoV-2 Ag RDT is a test based on lateral flow technology. The test strips are housed in a cassette for compatibility with the EuGeni fluorescent strip reader. The LoD of the test is 2.8x10^5 genome copies/mL. The SARS-CoV-2 Ag RDT is intended to be used by healthcare professionals for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasopharyngeal specimens collected from individuals who are suspected of COVID-19 infection.

https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/2376