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Sm RNP IgG ELISA
DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-2785 · UDI-DI 04048474027853
LJM
Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
26
Facilities
Description
The Sm/RNP ELISA Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Sm/RNP in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders
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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