ARTG 480806Thrombophilia and coagulation inhibitor IVDs
ARTG ID: 480806 · Elitechgroup Australia Pty Ltd · ELITechGroup SpA · Class IIb · Started February 25, 2025
Good Name: Elitechgroup Australia Pty Ltd - Thrombophilia and coagulation inhibitor IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 480806
- Start Date
- February 25, 2025
- Effective Date
- February 25, 2025
- Name
- ELITechGroup SpA
- Country
- Italy
- Address
- Corso Svizzera 185, Torino, 10149
The product Coagulation ELITe MGB® Kit is an in vitro diagnostic medical device intended to be used as qualitative nucleic acids RealTime PCR assay for the allelic discrimination of the following three loci in human genomic DNA samples extracted from clinical specimens: - coagulation Factor V gene, single nucleotide polymorphism (SNP) G1691A (Leiden), - coagulation Factor II gene, SNP G20210A, - 5,10-methylenetetrahydrofolate reductase (MTHFR) gene, SNP C677T. The product is intended for use as an aid in assessing the risk of deep vein thrombosis in patients suspected of having coagulation disorders and at risk of deep vein thrombosis.
Access comprehensive regulatory information for Thrombophilia and coagulation inhibitor IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 480806 and sponsored by Elitechgroup Australia Pty Ltd, manufactured by ELITechGroup SpA in Italy. The device registration started on February 25, 2025.
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