Clinical chemistry biological screening IVDs

Intended purpose

CT1236 Clinical chemistry biological screening IVDs IVDs that are intended to be used for the qualitative and/or quantitative screening of urine, faeces and other biological specimens for chemical, cellular or other components using a dipstick or other broadly indicative method. Biological fluid occult blood, vaginal pH, faecal screening tests for faecal (meconuim) albumin, faecal fat, faecal occult blood, faecal reducing substance, and urine screening tests for bilirubin, blood, creatinine, glucose, ketone, leukocyte, nitrite, pH, protein, sediment, specific gravity, urobilinogen.