Clinical chemistry substrate IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
18-10-2022
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Available from:
Abacus dx Pty Ltd
Class:
Class 2
Manufactured by:
Aidian Oy Koivu-Mankkaan tie 6 B PO Box 83, Espoo, Finland, FI-02101 Finland
Therapeutic area:
CT833 - Clinical chemistry substrate IVDs
Therapeutic indications:
IVDs used on the QuikRead go instrument for the qualitative and/or quantitative determination of clinical chemistry substrates in a clinical specimen, including HbA1c for monitoring long term control of glucose from diabetes mellitus or as an aid in diagnosing diabetes. These assays and controls are intended to be used by trained healthcare professionals in clinical laboratories and/or near-patient/point-of-care testing settings.
Authorization status:
A
Authorization date:
2022-10-04
