Reagent Kit
HPLC Reagent Kit for automated sample preparation, Vitamin C in plasma/serum
10manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jilin (5), Zhejiang (2), Guangxi (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| 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 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
Record
| Listed by | Chromsystems Instruments & Chemicals Gmbh, Germany |
|---|---|
| FDA product code | JMA |
| Device type | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1095 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-27 |
| Record revised | 2022-07-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2022-07-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 65065 | 100 analyses | In distribution |
| 65765/F | 480 analyses | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Accessorie | Chromsystems Instruments & Chemicals Gmbh | 3 |
| Reagent | Chromsystems Instruments & Chemicals Gmbh | 2 |
| Ucare 11 Stick | YD Diagnostics | 1 |
| Contec | Contec Medical Systems Co., Ltd. | 1 |
| Rapid Response | Btnx Inc. | 1 |
| Vitamin C (Ascorbic Acid) | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
| Vitamin C (Ascorbic Acid) | DRG International, 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.