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Immunoelectrophoretic, Immunoglobulins, (G, A, M)
FDA product code CFF · Class 2 · Immunology
89
Registered devices
2
Adverse events
4
Recalls
29
510(k) clearances
Devices with this code
SPIFE Ultra ImmunoFix-15 Antisera Kit — HELENA LABORATORIES CORPORATIONSPIFE 4000 IFE Antisera Kit — HELENA LABORATORIES CORPORATIONSPIFE IgG IEF-10 Kit — HELENA LABORATORIES CORPORATIONNormal Human Serum Control — HELENA LABORATORIES CORPORATIONK-ASSAY® IgM Reagent — KAMIYA BIOMEDICAL COMPANY, LLCSPIFE ImmunoFix-3 Gel Kit — HELENA LABORATORIES CORPORATIONSPIFE ImmunoFix-9 Gel Kit — HELENA LABORATORIES CORPORATIONTitan IV IEPlates — HELENA LABORATORIES CORPORATIONSPIFE ImmunoFix-15 Applicator Kit — HELENA LABORATORIES CORPORATIONAntiserum to Human IgE — HELENA LABORATORIES CORPORATIONSample Diluent CAPI 3 IT (10) — SEBIASPIFE 4000 IFE Gel Kit — HELENA LABORATORIES CORPORATIONANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 IF MAXI-KIT (STANDARD MASK) — SEBIATitan IV IEPlates — HELENA LABORATORIES CORPORATIONSPIFE ULTRA IFE-6 ANTISERA KIT — HELENA LABORATORIES CORPORATIONHYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK) — SEBIASPIFE IFE-9 Pentavalent Antisera Kit — HELENA LABORATORIES CORPORATIONSPIFE Ultra ImmunoFix-6 Antisera Kit — HELENA LABORATORIES CORPORATIONBlade Applicator Kit, 12 Sample — HELENA LABORATORIES CORPORATIONSPIFE Nexus Antisera 9/15 Kit — HELENA LABORATORIES CORPORATIONSPIFE ImmunoFix-15 Gel Kit — HELENA LABORATORIES CORPORATIONCAPILLARYS IMMUNOTYPING — SEBIAAntisera to Human Immunoglobulins Pentavalent (G, A, M, D, E) — HELENA LABORATORIES CORPORATIONQuickGel IFE Antisera Kit — HELENA LABORATORIES CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-09-28 | Kamiya Biomedical Company, LLC | IgA Reagent may start showing cloudiness over time, which can affect assay performance. |
| 2022-04-06 | Helena Laboratories, Corp. | Due to microbial growth causing interference with interpretation. |
| 2017-07-21 | Helena Laboratories, Corp. | The plates do not have wells punched for the controls in the patient 1 area. |
| 2004-01-28 | Beckman Coulter Inc | Inconsistent and incomplete results for IgG. |
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