SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies and consists of SPMG_A and SPMG_L. The SpermMar Test IgG is a diagnostic kit for detecting antisperm…
SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies and consists of SPMG_A and SPMG_L. 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
Who Else Makes It
Registered in Shandong.
Record
Regulatory record for SpermMar Test IgG – 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 | 2019-12-11 |
| 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.