Instrument/analyser IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
07-11-2017
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Available from:
Beckman Coulter Australia Pty Ltd
Class:
Class 1
Manufactured by:
Beckman Coulter Mishima KK 454-32 Higashino, Nagaizumi-cho, Sunto-gun Shizuoka, 411-0931 Japan
Therapeutic area:
CT943 - Instrument/analyser IVDs
Therapeutic indications:
Manual, semi-automated equipment or apparatus that are intended by the manufacturer to be used as an in vitro diagnostic medical device (IVD) for the purposes of processing, examining and/or providing information about a clinical specimen.
Authorization status:
Included - IVD
