Home › Fertipro NV › SpermMar Test IgG - single kit
SpermMar Test IgG - single kit
Fertipro NV · Model SPMG_S · UDI-DI 05411967000036
2
510(k) clearances
5
Adverse events
2
Recalls
5
Facilities
Description
SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies. The SpermMar Test IgG is a diagnostic kit for detecting antisperm antibodies of the IgG class in human semen or serum. The direct SpermMar Test IgG can be performed on untreated human semen provided it contains motile spermatozoa, the indirect SpermMar Test IgG can be used on serum. 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.