Summary for ARTG Entry:
Bio-Rad Laboratories Pty Ltd - Genscreen HIV-1 Antigen Assay - HIV1 antigen IVD, kit, enzyme
ARTG entry for
Medical Device Included - IVD Class 4
Bio-Rad Laboratories Pty Ltd
PO Box 752,GLADESVILLE, NSW, 1675
ARTG Start Date
Medical Device Class 4
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
3 Boulevarde Raymond Poincare
, MARNES-LA-COQUETTE, 92430
1. Genscreen HIV-1 Antigen Assay - HIV1 antigen IVD, kit, enzyme immunoassay (EIA)
48458 HIV1 antigen IVD, kit, enzyme immunoassay (EIA)
The Genscreen™ HIV-1 Antigen Assay is intended to be used as a screen for donated blood and plasma
and as an aid in the diagnosis and prognosis of HIV-1 infection.
The Genscreen™ HIV-1 Antigen Assay is intended to be used as an aid in the diagnosis and prognosis of
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:27:19 AEDT
This is not an ARTG Certificate document.
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