Fertility Solutions
Sperm Count Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 levels - high and low concentrations.
3manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
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 | Fertility Solutions, Inc., United States |
|---|---|
| FDA product code | NRF |
| Device type | Material, Quality Control, Semen Analysis |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-30 |
| Record revised | 2023-10-31 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | expiry date, serial number |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2023-10-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FSI211 | 150 microliters per vial | In distribution |
| FSI103 | 300 microliters per vial | In distribution |
| FSI203 | 150 microliters per vial | In distribution |
| FSI111 | 300 microliters per vial | In distribution |
| FSI211 | 150 microliters per vial | Withdrawn |
| FSI111 | 300 microliters per vial | Withdrawn |
| FSI103 | 300 microliters per vial | Withdrawn |
| FSI203 | 150 microliters per vial | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| accu-beads® | Hamilton Thorne, Inc. | 1 |
| QwikCheck Beads Precision and Linearity kit | M.E.S. Medical Electronic Systems Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K041240 | 2004-06-02 |
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.