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System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

FDA product code MSV · Class 2 · Immunology

78
Registered devices
0
Adverse events
1
Recalls
46
510(k) clearances

Devices with this code

DIASTAT anti-B2 Glycoprotein-1 IgG — Svar Life Science ABQUANTA Lite® β2GPI IgM ELISA — INOVA DIAGNOSTICS, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.QUANTA Flash® β2GPI IgG Reagents — INOVA DIAGNOSTICS, INC.AESKULISA® ß2-Glyco-Check — Aesku.Diagnostics GmbH & Co. KGAESKULISA® ß2-Glyco-A — Aesku.Diagnostics GmbH & Co. KGQUANTA LITE® B2 GPI IgA ELISA Bulk Pack Kit (Lab Corp) — INOVA DIAGNOSTICS, INC.QUANTA Lite® β2GPI IgA ELISA Bulk Pack — INOVA DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.AESKULISA® ß2-Glyco-A — Aesku.Diagnostics GmbH & Co. KGAutostat II Anti-B2-Glycoprotein I IgG — HYCOR BIOMEDICAL LLCImmco Diagnostics, Inc. — IMMCO DIAGNOSTICS, INC.Autostat II Anti-B2-Glycoprotein I IgM — HYCOR BIOMEDICAL LLCAutoimmune EIA — BIO-RAD LABORATORIES, INC.AESKULISA® ß2-Glyco-A — Aesku.Diagnostics GmbH & Co. KGQUANTA LITE® B2 GPI IgM ELISA Bulk Pack Kit (Lab Corp) — INOVA DIAGNOSTICS, INC.QUANTA Lite® β2GPI IgG ELISA — INOVA DIAGNOSTICS, INC.QUANTA Lite® β2GPI IgA — INOVA DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.AESKULISA® ß2-Glyco-GM — Aesku.Diagnostics GmbH & Co. KGQUANTA Flash® β2GPI IgM Reagents — INOVA DIAGNOSTICS, INC.AESKULISA® ß2-Glyco-GM — Aesku.Diagnostics GmbH & Co. KG

Recent recalls

DateFirmReason
2004-10-26Diasorin Inc.Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be g

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