Singapore legislation

Regulation 34

Conduct of simple in vitro diagnostic test

A licensee must ensure that any simple in vitro diagnostic test on a specimen or a patient must be conducted —

(a)

using testing material in respect of which —

(i)

the expiry date has not passed; and

(ii)

the personnel who is administering the test does not suspect or have any reason to suspect that the testing material is no longer fit for use; and

(b)

in accordance with the instructions specified by the manufacturer of the testing material.