Accu-Beads®
accu-beads® are intended for use as a quality control material to assist in verifying the accuracy and precision of manual and automated sperm concentration measurements.
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 | Hamilton Thorne, Inc., United States |
|---|---|
| FDA product code | NRF |
| Device type | Material, Quality Control, Semen Analysis |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-03-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| accu-beads® | 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 |
| QwikCheck Beads Proficiency and Training Kit | M.E.S. Medical Electronic Systems Ltd. | 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.