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Colorimetric Method, Triglycerides

FDA product code JGY · Class 1 · Clinical Chemistry

64
Registered devices
6
Adverse events
2
Recalls
22
510(k) clearances

Devices with this code

Mission Cholesterol Optical Check Device — Acon Laboratories, Inc.STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — SD Biosensor, Inc.STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — SD Biosensor, Inc.Cholestech LDX™ — Alere San Diego, Inc.Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25T — Acon Laboratories, Inc.Assy Vial, Lipid Panel Test Strips, 1 ct, CardioChek Plus Home — POLYMER TECHNOLOGY SYSTEMS, INC.Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk) — POLYMER TECHNOLOGY SYSTEMS, INC.Blood Lipid Analyzer — Urit Medical Electronic Co., Ltd.PTS Panels® Triglycerides Test Strips — POLYMER TECHNOLOGY SYSTEMS, INC.CardioChek — HENRY SCHEIN, INC.Alere Cholestech LDX® — Alere San Diego, Inc.CardioChek — HENRY SCHEIN, INC.Alere Cholestech LDX® — Alere San Diego, Inc.STANDARD™ LipidoCare Analyzer — SD Biosensor, Inc.CardioChek® Analyzer; Refurbished — POLYMER TECHNOLOGY SYSTEMS, INC.Blood Lipid Test Strip — Urit Medical Electronic Co., Ltd.CURO L5 Meter — OSANG HEALTHCARE Co., Ltd.AimStrip Tandem Total Triglycerides Test Strips — GERMAINE LABORATORIES, INCSTANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — SD Biosensor, Inc.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.AimStrip Tandem Lipid Profile and glucose measuring system — GERMAINE LABORATORIES, INCAssy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus Home — POLYMER TECHNOLOGY SYSTEMS, INC.Mission Cholesterol Meter — Acon Laboratories, Inc.Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5T — Acon Laboratories, Inc.

Recent recalls

DateFirmReason
2025-04-24Mckesson Medical-Surgical Inc. Corporate Officetransit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con
2025-04-24Mckesson Medical-Surgical Inc. Corporate Officetransit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con

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