4 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: Sweden
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RetraLight LED Light Retractor
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·PulseLavage AB·1 device
RetraLight LED Light Retractor (without Teeth)
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·PulseLavage AB·1 device
DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.
FDA Enforcement
Class II
·Terminated·Euro Diagnostica AB·March 14, 2018
Lea Reg AB
Authorized representative
🇸🇪 Sweden·1 Manufacturer