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SpermMar Test IgA - single kit
Fertipro NV · Model SPMA_S · UDI-DI 05411967002566
2
510(k) clearances
5
Adverse events
2
Recalls
5
Facilities
Description
SpermMar Test IgA is a qualitative beads test for detection of sperm antibodies of the IgA class. The Spermar Test IgA is a diagnostic kit for detecting antisperm antibodies of the IgA class in human semen. The presence of antisperm antibodies can interfere with sperm function and zona binding and the acrosome reaction. More information can be found at the FertiPro website: www.fertipro.com
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 certain samples when th |
| 2003-05-07 | Ventana Medical Systems Inc | Kit does not stain tissues properly. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.