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ANA Combi (ANA-8-Profile) ELISA
DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-3563 · UDI-DI 04048474035636
LJM
Prescription
10
510(k) clearances
0
Adverse events
2
Recalls
26
Facilities
Description
ANA Combi ELISA is a test system for the qualitative measurement of ANA autoantibodies directed against RNP-70, RNP/Sm, Sm, SS-A (52 and 60 kDa), SS-B, Scl-70, Centromere B and Jo-1 in human serum or plasma.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-08-27 | Calbiotech Inc | The recall was initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. The firm reported although there is no potential health hazard related to |
| 2008-08-19 | Zeus Scientific Inc | The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.