LW Scientific
8 Key Digital Differential Counter
8manufacturers in China registered for this device type
1catalogue number
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 | LW Scientific, Inc., United States |
|---|---|
| FDA product code | GHO |
| Device type | Hemocytometer |
| Device class | Class 1 |
| Regulation | 21 CFR 864.6160 |
| Establishment | Remanufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-01-23 |
| Record revised | 2023-02-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CTL-DIFD-08KP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| C-Chip | Nanoentek Inc | 11 |
| LensHooke Semen Test Slide | Bonraybio Co., Ltd. | 4 |
| Fertility Solutions | Fertility Solutions, Inc. | 2 |
| 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 |
| 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.