SpermMar IgG Negative Control
Catalogue number 15517, listed by Vitrolife Inc., United States, under Sperm, Antigen, Antiserum, Control. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (3), Zhejiang (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
Record
| Listed by | Vitrolife Inc., United States |
|---|---|
| FDA product code | DFQ |
| Device type | Sperm, Antigen, Antiserum, Control |
| Device class | Class 1 |
| Regulation | 21 CFR 866.5800 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-04-23 |
| Record revised | 2020-04-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15517 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sperm Antibody Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 4 |
| Sperm Antibody Elisa | DRG International, Inc. | 2 |
| SpermMar IgA Latex Particles | Vitrolife Inc. | 1 |
| SpermMar IgG Latex Particles | Vitrolife Inc. | 1 |
| Sperm Antibody Elisa | Diasource Immunoassays, S.A. | 1 |
| SpermMar IgG Positive Control | Vitrolife Inc. | 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.