Fertility Solutions
Spermocytometer® sperm counting chambers. Box of 25 disposable slides each containing 2 single use counting chambers. 20 micron deep fixed coverslip glass chambers. Requires the use of an…
Spermocytometer® sperm counting chambers. Box of 25 disposable slides each containing 2 single use counting chambers. 20 micron deep fixed coverslip glass chambers. Requires the use of an eyepiece reticle.
8manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (2), Shandong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Zhejiang Saining Biotechnology Co., Ltd. | Taizhou | Zhejiang | Manufacturer | 12 |
Record
| Listed by | Fertility Solutions, Inc., United States |
|---|---|
| FDA product code | GHO |
| Device type | Hemocytometer |
| Device class | Class 1 |
| Regulation | 21 CFR 864.6160 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-15 |
| Record revised | 2023-10-31 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | serial number |
| Sizes | Depth 20 µm |
| Distribution end date | 2023-10-29 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SA400 | Depth 20 µm | 25 | In distribution |
| SA400 | Depth 20 µm | 25 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| C-Chip | Nanoentek Inc | 11 |
| LensHooke Semen Test Slide | Bonraybio Co., Ltd. | 4 |
| MicroCell | Vitrolife Inc. | 2 |
| LensHooke Prestained Morphology Slide | Bonraybio Co., Ltd. | 2 |
| LW Scientific, Inc. | LW Scientific, Inc. | 1 |
| Hemocytometer (CE) Neubauer improved | Bioanalytic GmbH, biomed. Analysentechnik | 1 |
| LW Scientific | LW Scientific, Inc. | 1 |
| Hemocytometer Neubauer improved, disposable, made of glass. | Bioanalytic GmbH, biomed. Analysentechnik | 1 |
| Hemocytometer (CE) Fuchs-Rosenthal brightline | Bioanalytic GmbH, biomed. Analysentechnik | 1 |
| Hemocytometer (CE) Neubauer improved brightline | Bioanalytic GmbH, biomed. Analysentechnik | 1 |
| Hemocytometer (CE) Fuchs-Rosenthal | Bioanalytic GmbH, biomed. Analysentechnik | 1 |
| Cover Slips (for Hemacytometer) | Bioanalytic GmbH, biomed. Analysentechnik | 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.