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South Africa. REGULATORY REQUIREMENTS FOR COVID-19 RAPID TEST KITS 2. COVID-19 Rapid Test Kits are classified as Class D Medical Devices according to Classification Rule 1 for IVDS - Detection of transmissible agents posing a high public health risk.Rapid COVID Antibody Test - EpicentreThe Orient Gene COVID-19 IgG/IgM Rapid Test Cassette. This is the first COVID-19 antibody test that has been approved for use in South Africa. The specificity of this test is 100% and it has a sensitivity of 95.8% for samples collected 10 days or more after the onset of symptoms or a positive PCR (nasal test) result (McAdam, 2020).Reliable Diagnostic SuppliesWelcome to the official website of Reliable Diagnostic Supplies (Pty) Ltd. We are a South African medical diagnostics company which imports and distributes niche, medical devices, diagnostic and research products to the Southern African market. We partner with reputable manufacturers globally to source laboratory products of great quality, at south african igm rapid test kit for sale
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