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Anti-Measles Virus NP ELISA (IgM)
EUROIMMUN Medizinische Labordiagnostika AG · Model EI 2610-9601-4 M · UDI-DI 04049016092520
1
510(k) clearances
1
Adverse events
3
Recalls
2
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-17 | Quest International, Inc. | Measles IgM Test Kit lacks premarket approval or clearance. |
| 2021-03-17 | Clark Laboratories, Inc. | Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting |
| 2016-07-11 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of ran |
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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.