Home › Device types › PCL
Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
FDA product code PCL · Class 1 · Microbiology
6
Registered devices
1
Adverse events
3
Recalls
1
510(k) clearances
Devices with this code
Anti-Measles Virus ELISA (IgM) — EUROIMMUN Medizinische Labordiagnostika AGAnti-Measles Virus NP ELISA (IgM) — EUROIMMUN Medizinische Labordiagnostika AGTrinity Biotech — CLARK LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.AccuDiag™ — Diagnostic Automation, Inc.ASI Measles IgM EIA Test — ARLINGTON SCIENTIFIC, INC.
Recent 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 (run |
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