Device Dossier
Treponema (syphilis) IVDs
Device Dossier for Treponema (syphilis) IVDs (CT799 - Treponema (syphilis) IVDs, Class 3, sponsor Edwards Group). ARTG record, intended purpose, GMDN…
- GMDN category: CT799 - Treponema (syphilis) IVDs
Intended purpose
The ASI RPR (rapid plasma reagin) Card Test for syphilis is a qualitative and semiquantitative nontreponemal flocculation test for the detection of reagin antibodies in human serum and plasma as a screening test for serological evidence of syphilis. The ASI RPR Card Test for Syphilis is for professional use only.