Panels › Microbiology › Product code PCL · Class 1
Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Regulation 866.3520
0510(k)s in 12 months (1 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in PCL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2025 | Quest International, Inc. Brand Name: ReQuest Measles IgM
Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM
Model/Catalog Number: 01-190M
Software Version: N/A
Product Description: Measles IgM tests, performed usi Open, Classified |
PCL | None listed |
| Mar 17, 2021 | Clark Laboratories, Inc. Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) Terminated |
PCL | K140455 |
| Sep 12, 2016 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD Terminated |
PCL | K140455 |
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