7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Sweden
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Pentaflex
Device
EU MDR
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Eu Md Class 1
·ArjoHuntleigh AB·On the market·14 countries
Fidget-tub enkel, blå
Device
EU MDR
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Eu Md Class 1
·Adaptis Spektra AB·On the market
Fidget-tub nyckelring, blå
Device
EU MDR
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Eu Md Class 1
·Adaptis Spektra AB·On the market
Fidget-tub två kulor, blå
Device
EU MDR
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Eu Md Class 1
·Adaptis Spektra AB·On the market
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
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) 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.
FDA Enforcement
Class III
·Terminated·Euro Diagnostica AB·July 5, 2017
4130113389
Certificate
MDD Annex II (excluding section 4)·TLA Targeted Immunotherapies AB·INTERTEK SEMKO AB·1 Basic UDI-DI