8 results
·
51ms
·
Sources: EU EUDAMED, US FDA
AMAX 190 PLUS
FDA Adverse Event
Malfunction
·SIGMA DIAGNOSTICS, INC.·Product code JPA·October 11, 2000
Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.
FDA Recall
Terminated
·Zeus Scientific Inc·Product code MID·June 22, 2001
Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.
FDA Recall
Terminated
·Zeus Scientific Inc·Product code DHR·November 9, 2001
Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B
FDA Recall
Terminated
·Zeus Scientific Inc·Product code LFX·February 24, 2000
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices
Amstermed B.V.
Authorized representative
🇳🇱 Netherlands·50 Manufacturers·272 Devices
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices
RIOMAVIX LTD
Authorized representative
🇪🇸 Spain·400 Manufacturers·4531 Devices