Print-ready dossier — use your browser's print dialog to save as PDF.
Anti-Cardiolipin IgG/IgM ELISA
Model EIA-3587 · DRG International Inc · DI 00840239035875
MID — System, Test, Anticardiolipin Immunological · Class II · 21 CFR 866.5660
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2023-03 | 0 | 1 |
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — DRG International Inc
- VAI 2019-04-15 DRG International, Inc. · 6 citations
- VAI 2014-11-26 DRG International, Inc. · 3 citations
- VAI 2012-07-11 DRG International, Inc. · 2 citations