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SSB (La) IgG ELISA

DRG International Inc · Model EIA-2783 · UDI-DI 00840239027832

LJM Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
26
Facilities

Description

The DRG SSB (La) ELISA is a semi-quantitative immunoassay for the detection of IgG antibodies to SSB in human sera.

Recalls

DateFirmReason
2008-08-27Calbiotech IncThe 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
2008-08-19Zeus Scientific IncThe 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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Data 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.