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ANTI-SS-B
ORGENTEC Diagnostika GmbH · Model ORG509 · UDI-DI 04260157080065
LJM
Prescription
10
510(k) clearances
0
Adverse events
2
Recalls
26
Facilities
Description
ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-B (La) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
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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