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System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
FDA product code MSV · Class 2 · Immunology
79
Registered devices
0
Adverse events
1
Recalls
46
510(k) clearances
Devices with this code
QUANTA Lite® β2GPI IgA — INOVA DIAGNOSTICS, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.Corgenix Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (192 Well) — CORGENIX MEDICAL CORPORATIONHemosIL CL Anti-ß2 Glycoprotein-I IgM — INSTRUMENTATION LABORATORY COMPANYImmco DIagnostics, Inc. — IMMCO DIAGNOSTICS, INC.AESKULISA® ß2-Glyco-GM — Aesku.Diagnostics GmbH & Co. KGAESKULISA® ß2-Glyco-Check — Aesku.Diagnostics GmbH & Co. KGAutoimmune EIA — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Aptiva® APS IgG Reagent — INOVA DIAGNOSTICS, INC.AESKULISA® ß2-Glyco-GM — Aesku.Diagnostics GmbH & Co. KGIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.QUANTA Lite® β2GPI IgM ELISA — INOVA DIAGNOSTICS, INC.AESKULISA® ß2-Glyco-Check — Aesku.Diagnostics GmbH & Co. KGBioPlex 2200 — BIO-RAD LABORATORIES, INC.QUANTA LITE® B2 GPI IgA ELISA Bulk Pack Kit (Lab Corp) — INOVA DIAGNOSTICS, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.QUANTA Flash® β2GPI IgM Reagents — INOVA DIAGNOSTICS, INC.QUANTA Lite® β2GPI IgA ELISA Bulk Pack — INOVA DIAGNOSTICS, INC.Anti-Beta 2 Glycoprotein Screen ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.QUANTA Flash® B2GP1 IgM Reagents — INOVA DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-10-26 | Diasorin 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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