SpermMar IgG Negative Control
SpermMar IgG Negative Control: Control for use with the Indirect Test for Determination of Sperm Antibodies (SpermMar IgG). More information can be found on the FertiPro website:…
SpermMar IgG Negative Control: Control for use with the Indirect Test for Determination of Sperm Antibodies (SpermMar IgG). More information can be found on the FertiPro website: www.fertipro.com
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| 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 | 2023-04-28 (version 4) |
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 2.5 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPMG_N | Total Volume 2.5 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 8 |
| SpermMar Test IgG – single kit | Fertipro NV | 3 |
| SpermMar Test IgG – Complete kit | Fertipro NV | 1 |
| SpermMar Test IgA – single kit | Fertipro NV | 1 |
| SpermMar Test IgA – complete kit | Fertipro NV | 1 |
| SpermMar IgG Positive Control | Fertipro NV | 1 |
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.