ARTG 474567Clinical chemistry hormone IVDs
ARTG ID: 474567 · Abacus dx Pty Ltd · Response Biomedical Corporation · Class IIa · Started December 23, 2024
Good Name: Abacus dx Pty Ltd - Clinical chemistry hormone IVDs
- Risk Class
- Class IIa
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 474567
- Start Date
- December 23, 2024
- Effective Date
- December 23, 2024
- Country
- Canada
- Address
- 1781 75th Avenue West, Vancouver, British Col, V6P 6P2
The RAMP Total b-hCG test is a quantitative immunochromatographic assay indicated for use as an in vitro diagnostic product used with a RAMP 200 instrument to measure levels of beta-human chorionic gonadotropin (b-hCG) in human EDTA anti-coagulated whole blood. RAMP Total b-hCG is intended for use in conjunction with other laboratory findings and clinical assessments to aid in the determination of early pregnancy. The RAMP Total β-hCG Controls are intended for in vitro diagnostic use in the quality control of the RAMP Total β-hCG assay on the RAMP Platform.
Access comprehensive regulatory information for Clinical chemistry hormone IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 474567 and sponsored by Abacus dx Pty Ltd, manufactured by Response Biomedical Corporation in Canada. The device registration started on December 23, 2024.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.