FDA-Device2019-07-10Class II
EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000.
Phadia Ab
Hazard
Potential for reporting low assay results
Sold states
US Nationwide n the states of NJ, NY, MI, WV, TX including PR
Affected count
30 kits
Manufactured in
Rapsgatan Plant, Rapsgatan 7, Uppsala, N/A, Sweden
Products
EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1907-2019Don't want to check this manually?
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