Intended Use: One Step Syphilis Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Treponema Pallidum (TP) to aid in the diagnosis of Syphilis.
Product Name: (TP) Anti-Syphilis Test (Cassette).
Accessories: Instruction for use, buffer, sterile lancet, pipette.
Principle of Test: Immunochromatographic assay.
Product Performance: Sensitivity: 99.20%.
We supply OEM: Private label test kits for pharmaceutical and laboratory groups that want to create their own brand.
Having successfully completed the CE marking, available for use in Europe (CE).
Manufacturing company with CE, issued as OEM, in compliance with Directive 98/79EC of the European Parliament and of the council of in vitro diagnostic Medical devices, according to Annex III.
ISO 13485 certification.