Cobas® cfDNA Sample Preparation Kit
Catalogue number 1.0, listed by Roche Molecular Systems, Inc., United States, under Clinical Sample Concentrator. 27 manufacturers in China are registered for this product code.
27manufacturers in China registered for this device type
1catalogue number
5recalls on this 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 | Roche Molecular Systems, Inc., United States |
|---|---|
| FDA product code | JJH |
| Device type | Clinical Sample Concentrator |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2310 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-11-06 |
| Record revised | 2021-02-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.0 | 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
4 of these are 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 |
|---|---|---|---|---|---|
| 2020-06-03 | Class II | Software change control | When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA Pure 96 instrument, which introduces a potential risk for cross-contamination leading to erroneous results. | 917 | 2023-10-04 |
| 2018-05-02 | Class II | Software in the Use Environment | Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run. | 163 units | 2019-04-30 |
| 2016-03-03 | Class II | Labeling design | The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID. | 6,939 pieces | 2017-05-25 |
| 2012-10-11 | Class II | Device Design | Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots. | 7 units | 2013-09-11 |
| 2009-06-02 | Not classified | Software design | Software bug: A unique series of events involving the COBAS AmpliPrep instrument running AMPLILINK software version 3.2.2 that results in specimens being amplified and detected with the wrong parameters. The error can occur on either COBAS | 282 | 2010-08-13 |
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.