ARTG 461373Haematology calibrator/control IVDs
ARTG ID: 461373 · Revvity Pty Ltd · Wallac Oy · Class IIa · Started August 29, 2024
Good Name: Revvity Pty Ltd - Haematology calibrator/control IVDs
- Risk Class
- Class IIa
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 461373
- Start Date
- August 29, 2024
- Effective Date
- August 29, 2024
- Name
- Revvity Pty Ltd
- Name
- Wallac Oy
- Country
- Finland
- Address
- Mustionkatu 6, Turku, FI-20750
The kit is intended to be used as a control in isoelectric focusing on electrophoresis gels. Relative positions of hemoglobin variants A, F, S, and C in the control are used in monitoring assay performance acceptability and in qualitative identification of normal and variant hemoglobin in human blood samples. The kit is intended to be used by trained laboratory personnel.
Access comprehensive regulatory information for Haematology calibrator/control IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 461373 and sponsored by Revvity Pty Ltd, manufactured by Wallac Oy in Finland. The device registration started on August 29, 2024.
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