Sperm Antibody Elisa
The DRG Sperm Antibody (seminal plasma) ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of antibodies directed against human spermatozoa in seminal…
The DRG Sperm Antibody (seminal plasma) ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of antibodies directed against human spermatozoa in seminal plasma.
5manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | DRG International, Inc., United States |
|---|---|
| FDA product code | DFQ |
| Device type | Sperm, Antigen, Antiserum, Control |
| Device class | Class 1 |
| Regulation | 21 CFR 866.5800 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2023-08-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EIA-4249 | In distribution | |
| EIA-1826 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sperm Antibody Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 4 |
| 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 |
| SpermMar IgG Negative 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.