Instrument/analyser IVDs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
19-10-2022
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Available from:
Hologic (Australia & New Zealand) Pty Ltd
Class:
Class 1
Manufactured by:
Hologic Inc 10210 Genetic Center Drive, San Diego, CA, 92121 United States Of America
Therapeutic area:
CT943 - Instrument/analyser IVDs
Therapeutic indications:
The PeriLynx system is an in vitro diagnostic device intended to be used in conjunction with the Rapid fFN 10Q cassette, the Rapid fFN control kit, and the PeriLynx QCette for the detection of fetal fibronectin (fFN) in cervicovaginal secretions. The PeriLynx system is a Point of Care device.
Authorization status:
A
Authorization date:
2022-06-21
