ARTG 338858PK7400 TP HA Assay - Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination
ARTG ID: 338858 · Beckman Coulter Australia Pty Ltd · Newmarket Biomedical Ltd · Class III · Started July 03, 2020
Good Name: Beckman Coulter Australia Pty Ltd - PK7400 TP HA Assay - Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination
- Risk Class
- Class III
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 338858
- Start Date
- July 03, 2020
- Effective Date
- July 03, 2020
- Country
- United Kingdom
- Address
- Unit 1 Lanwades Business Park, Kentford Newmarket, Suffolk, CB8 7PN
Reagent and controls which is intended for the qualitative screening of blood donors for the detection of Treponema pallidum IgG and IgM antibodies to syphilis in human serum or EDTA plasma using the Beckman Coulter PK7400 Automated Microplate System. This assay is not intended for diagnostic use.
Access comprehensive regulatory information for PK7400 TP HA Assay - Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 338858 and sponsored by Beckman Coulter Australia Pty Ltd, manufactured by Newmarket Biomedical Ltd in United Kingdom. The device registration started on July 03, 2020.
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