← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
DEVICE CLASS
Class II
REGULATION
21 CFR 866.3780
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES
Recent clearances
K242022Beckman Coulter, Inc. · 510k2025-03-28
K242095Beckman Coulter, Inc. · 510k2024-10-11
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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