Document ID: chunk:federal_register_of_legislation:F2022C01116:clause:1_1
Version: federal_register_of_legislation:F2022C01116
Segment Type: clause
Provision Reference: sch 1 cl 1
Character Range: 5985–7284

1                  testing specimens from the human body in relation to a serious disease, other than to:
                     (a) test for the presence of, or exposure to, any of the following pathogenic organisms or transmissible agents:
                         (i) chlamydia trachomatis;
                         (ii) hepatitis B virus;
                         (iii) hepatitis C virus;
                         (iv) herpes simplex virus type 1 and 2;
                         (v) human immunodeficiency virus type 1 and type 2;
                         (vi) seasonal influenza virus;
                         (vii) neisseria gonorrhoea;
                         (viii) treponema pallidum (syphilis); or
                     (b) diagnose, aid in diagnosis of, indicate the presence of, or test for the presence of markers that are precursors to, any of the following diseases or conditions, other than by genetic testing:
                         (i) diabetes;
                         (ii) kidney disease;
                         (iii) cardiovascular disease; or
                     (c) test for the presence of SARS-CoV-2 antigens or SARS-CoV-2 nucleic acid

Part 1—Class 2 IVD medical devices
Note: See section 5.

Excluded purposes
Column 1           Column 2
Item               Purposes