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…
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
Who Else Makes It
Registered in Shandong.
Record
Regulatory record for SpermMar Test IgA – single kit | Listed by | Fertipro NV, Belgium |
| FDA product code | KTO |
| Device type | Reagent, Immunoassay, Igg |
| Device class | Class 1 |
| Regulation | 21 CFR 866.5530 |
| Premarket notification | Exempt |
| Record published | 2018-08-22 |
| Record revised | 2026-05-07 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 0.7 ml |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.