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QMedix™
Diagnostic Automation, Inc. · Model DACD1301-1 · UDI-DI 00850054026019
3
510(k) clearances
0
Adverse events
1
Recalls
2
Facilities
Description
QMedix™ Rubella IgG ELISA This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Rubella virus in a clinical specimen, using an enzyme immunoassay (EIA) method.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-05-05 | Cell Marque Corporation | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as requir |
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