SectionStar
Catalogue number 810-00001, listed by Clarapath, Inc., United States, under Microtome, Rotary. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 11 |
| Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Dakewe(Shenzhen) Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
| RWD Life Science Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Clarapath, Inc., United States |
|---|---|
| FDA product code | IDO |
| Device type | Microtome, Rotary |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-16 |
| Record revised | 2024-10-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-10-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 810-00001 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Shandon Diagnostics Limited | 20 |
| Accu-Cut® SRM™ 200 | Sakura Finetek U.S.A., Inc. | 5 |
| Clarapath™ SectionStar™ | Clarapath, Inc. | 2 |
| Tissue-Tek® | Sakura Finetek U.S.A., Inc. | 2 |
| Accu-Cut® SRM™ 300 LT | Sakura Finetek U.S.A., Inc. | 2 |
| 2065A Auto Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 1 |
| LS-2065 Rotary Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 1 |
| MT1 Rotary Microtome | Dakewe(Shenzhen) Medical Equipment Co., Ltd. | 1 |
| Tissue-Tek AutoSection® | Sakura Finetek U.S.A., Inc. | 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.