Clinical chemistry-specific protein IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
03-11-2017
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Available from:
PM Separations Pty Ltd
Class:
Class 2
Manufactured by:
Recipe Chemicals & Instruments GmbH Dessauerstrasse 3, Munchen, 80992 Germany
Therapeutic area:
CT974 - Clinical chemistry-specific protein IVDs
Therapeutic indications:
The ClinMass? Complete Kit with order no. MS2000 is intended for the determination of homocysteine (total homocysteine) from human plasma or serum by LC-MS/MS. The ClinSpot? Complete Kit with order no. MS2100 is intended for the determination of homocysteine (total homocysteine) from dried blood spots (DBS) of human origin by LC-MS/MS.
Authorization status:
A
Authorization date:
2017-05-24
