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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-9 Gel Kit — HELENA LABORATORIES CORPORATIONANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 & 9 IF MAXI-KIT (DYNAMIC MASK) — SEBIAHYDRAGEL 4 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK) — SEBIAIT/IF Control — SEBIAAlbumin Marker — HELENA LABORATORIES CORPORATIONSPIFE Nexus IFE-6 Antisera Kit — HELENA LABORATORIES CORPORATIONV8 WASTE DRAWER PACK — HELENA LABORATORIES CORPORATIONBlade Applicator Kit, 18 Sample — HELENA LABORATORIES CORPORATIONANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 IF MAXI-KIT (STANDARD MASK) — SEBIAAntiserum to Human Serum — HELENA LABORATORIES CORPORATIONV8 Nexus CE Analyzer (115V/230V) — HELENA LABORATORIES CORPORATIONTitan IV IEPlates — HELENA LABORATORIES CORPORATIONSPIFE Ultra ImmunoFix-15 Antisera Kit — HELENA LABORATORIES CORPORATIONSPIFE ImmunoFix-3/6 Applicator Kit — HELENA LABORATORIES CORPORATIONHYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK) — SEBIAImmunofixation (IFE) Kit — THE BINDING SITE GROUP LIMITEDSPIFE ImmunoFix-9 Antisera Kit — HELENA LABORATORIES CORPORATIONNormal Human Serum Control — HELENA LABORATORIES CORPORATIONAntiserum to Human IgG, IgA and IgM — KENT LABORATORIES INCSPIFE ImmunoFix-9/15 Applicator Kit — HELENA LABORATORIES CORPORATIONSPIFE 4000 IFE Gel Kit — HELENA LABORATORIES CORPORATIONSPIFE Nexus IFE-9 Gel Kit — HELENA LABORATORIES CORPORATIONANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT (DYNAMIC MASK) — SEBIASPIFE Ultra ImmunoFix-9 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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