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Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

FDA product code DBL · Class 2 · Immunology

166
Registered devices
1
Adverse events
1
Recalls
24
510(k) clearances

Devices with this code

IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.CMA RT HRT Test(L) 96 — SCIMEDX CORPORATIONMeDiCa — SCIMEDX CORPORATIONMeDiCa — SCIMEDX CORPORATIONMeDiCa — SCIMEDX CORPORATIONR. KDY/STM Pack 8 WELL — SCIMEDX CORPORATIONMeDiCa — SCIMEDX CORPORATIONIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.MeDiCa — SCIMEDX CORPORATIONIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.M. KDY/STM Auto Pack 8 WELL — SCIMEDX CORPORATIONR. LVR/KDY/STM Pack 8 WELL — SCIMEDX CORPORATIONIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.R. HRT Pack 8 WELL — SCIMEDX CORPORATIONIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Autoscreen II(Ms) 48 Test(L) — SCIMEDX CORPORATIONMeDiCa — SCIMEDX CORPORATIONIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.MeDiCa — SCIMEDX CORPORATIONMeDiCa — SCIMEDX CORPORATIONIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.STR Muscle Test(L) 48 — SCIMEDX CORPORATION

Recent recalls

DateFirmReason
2008-07-29Bio-Rad LaboratoriesThe Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test

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