Centriprep-30K
2 catalogue numbers from 4306, listed by Merck Millipore Ltd., Ireland, under Clinical Sample Concentrator. 27 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (6), Guangdong (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Biomed Plastics Co. | Taicang | Jiangsu | Contract manufacturer | 29 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Changsha Renji Medical Equipment Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
| Phase Scientific (Shenzhen) Company Limited | Shenzhen | Guangdong | Repacker / relabeller | 8 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
Showing 12 of 27. All 27 manufacturers in China registered for Clinical Sample Concentrator
Record
| Listed by | Merck Millipore Ltd., Ireland |
|---|---|
| FDA product code | JJH |
| Device type | Clinical Sample Concentrator |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2310 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2022-05-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4306 | 24 | In distribution | |
| 4307 | 96 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TANBead Nucleic Acid Extraction Kit | Taiwan Advanced Nanotech Inc. | 124 |
| PCRopsis | Entopsis, Inc. | 53 |
| Bioer MagaBio plus Virus DNA /RNA Purification Kit III | Hangzhou Bioer Technology Co., Ltd. | 20 |
| m2000 | Abbott Molecular, Inc. | 19 |
| Allsheng | Hangzhou Allsheng Instruments Co., Ltd. | 13 |
| TANBead Nucleic Acid Extractor | Taiwan Advanced Nanotech Inc. | 12 |
| Bioer MagaBio plus Virus RNA Purification Kit II | Hangzhou Bioer Technology Co., Ltd. | 10 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 9 |
| BioTeke | Bioteke Corporation (Wuxi) Co., Ltd. | 8 |
| Prochem | Vivaproducts, Inc. | 8 |
| Vivafree 500 | Sartorius Stedim Lab Ltd. | 6 |
| Amicon Ultra → 4 | Merck Millipore Ltd. | 6 |
Showing 12 of 268. All products under Clinical Sample Concentrator
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-05-14 | Class II | Process control | In vitro diagnostic devices, used greater than 6 months after date of manufacture, may have increased concentration times of greater than the specification of 3 hours and up to 24 hours, which may lead to delays in carrying out the subseque | 1360 units | 2021-08-05 |
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.