FDA-Device2018-08-29Class II

Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.

Euro Diagnostica AB
Hazard

Decreasing performance overtime.

Sold states
Minnesota and Texas Foreign: Iran
Affected count
25 kits (US only)
Manufactured in
Box 50117, Lundavagen 151, Malmo, Sweden
Products
Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2918-2018

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