Home › Device types › KTO
Reagent, Immunoassay, Igg
FDA product code KTO · Class 1 · Immunology
15
Registered devices
5
Adverse events
2
Recalls
2
510(k) clearances
Devices with this code
SpermMar Test IgG - single kit — Fertipro NVSpermMar Test IgG - single kit — Fertipro NVSpermMar Test IgG - single kit — Fertipro NVBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.SpermMar Test IgG - Complete kit — Fertipro NVBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.SpermMar IgG Negative Control — Fertipro NVBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.SpermMar IgG Positive Control — Fertipro NVBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.SpermMar Test IgA - single kit — Fertipro NV
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-12-22 | Vitrolife Inc | The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new formulation causing the motility of sperm cells to reduce in cer |
| 2003-05-07 | Ventana Medical Systems Inc | Kit does not stain tissues properly. |
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