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Immunoassay, Insulin-Like Growth Factor Binding Protein-1

FDA product code OAM · Class 1 · Clinical Chemistry

9
Registered devices
7
Adverse events
1
Recalls
2
510(k) clearances

Devices with this code

IDS-iSYS Insulin like Growth Factor-1 (IGF-1) — IMMUNODIAGNOSTIC SYSTEMS LIMITEDIGF-1 ELISA — Diasource Immunoassays S.A. SAActim PROM — Actim OyIGFBP-3 Elisa — Diasource Immunoassays S.A. SAInsulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochr — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.Actim PROM Controls — Actim OyIGF-1-RIA-CT — Diasource Immunoassays S.A. SAInsulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochr — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.IDS-iSYS SDSpeed Calc — IMMUNODIAGNOSTIC SYSTEMS LIMITED

Recent recalls

DateFirmReason
2023-11-23ACTIM OYInterference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false pos

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.