QwikCheck Beads Proficiency and Training Kit
Catalogue number QwikCheck Beads Proficiency and Training, listed by M.E.S. Medical Electronic Systems Ltd., under Material, Quality Control, Semen Analysis. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Jilin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
Record
| Listed by | M.E.S. Medical Electronic Systems Ltd. |
|---|---|
| FDA product code | NRF |
| Device type | Material, Quality Control, Semen Analysis |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| 510(k) | K041600 |
| Record published | 2023-06-08 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| QwikCheck Beads Proficiency and Training Kit | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fertility Solutions | Fertility Solutions, Inc. | 8 |
| LensHooke X QC Reticle (For Semen) | Bonraybio Co., Ltd. | 8 |
| LensHooke X QC Video (For Semen) | Bonraybio Co., Ltd. | 5 |
| LensHooke X QC Slide (For Semen) | Bonraybio Co., Ltd. | 5 |
| Sperm-Chex | Streck LLC | 1 |
| LensHooke X QC Beads (For Semen) | Bonraybio Co., Ltd. | 1 |
| Sperm-Chex Post VC | Streck LLC | 1 |
| QwikCheck Beads | M.E.S. Medical Electronic Systems Ltd. | 1 |
| accu-beads® | Hamilton Thorne, Inc. | 1 |
| QwikCheck Beads Precision and Linearity kit | M.E.S. Medical Electronic Systems Ltd. | 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.