M2000
m2000 System Pierceable Cap Sample Rack PoSt Set
27manufacturers in China registered for this device type
19catalogue numbers in this listing
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 | Abbott Molecular, 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 |
| 510(k) | K092705 |
| Record published | 2016-09-01 |
| Record revised | 2023-09-29 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature up to -10 °C; Special storage condition: Protect from Light |
| Packaging | Case of 24, case of 6, case of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 01N93-01 | In distribution | ||
| 04J71-93 | In distribution | ||
| 01N97-01 | In distribution | ||
| 01N94-01 | In distribution | ||
| 01N06-01 | In distribution | ||
| 9K32-01 | In distribution | ||
| 04J72-82 | In distribution | ||
| 04J71-80 | 25 | In distribution | |
| 04J71-20 | 500 | In distribution | |
| 02N29-01 | In distribution | ||
| 04J71-17 | 96 | In distribution | |
| 01N92-02 | In distribution | ||
| 04J71-10 | 96 | In distribution | |
| 04J71-30 | In distribution | ||
| 04J71-60 | In distribution | ||
| 04J72-86 | In distribution | ||
| 9K31-01 | In distribution | ||
| 09K14-02 | In distribution | ||
| 04J71-45 | 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 |
| 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 |
| Vivafree 2 | Sartorius Stedim Lab Ltd. | 6 |
Showing 12 of 268. All products under Clinical Sample Concentrator
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Abbott Molecular, Inc. | 510(k) number | 2014-10-23 | Class II | Software design (manufacturing process) | Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error has occurred: Software error) to be generated when the Avai | 9 CD ROMs (US); 1,273 CD ROMs (Foreign) | 2016-03-08 |
| Abbott Molecular, Inc. | 510(k) number | 2014-06-19 | Class II | Employee error | Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV with an insufficient rim may not be held | 1,688,000 reaction vessels | 2016-02-23 |
| Abbott Molecular, Inc. | 510(k) number | 2013-11-23 | Class II | Nonconforming Material/Component | The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet. | 176 devices | 2017-12-04 |
| Abbott Molecular, Inc. | 510(k) number | 2012-12-04 | Class II | Software design | An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen, the changes are not saved. | 215 units – U.S., 693 units – ROW | 2016-03-08 |
| Abbott Molecular, Inc. | 510(k) number | 2011-10-11 | Not classified | Component design/selection | Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire. | 432 units | 2016-02-23 |
| Abbott Molecular, Inc. | 510(k) number | 2011-09-08 | Not classified | Software design | The Abbott m2000rt System software has software bug which can affect customers who manually enter a Test Order onto the m2000rt and sorts a column on the calibration or control grids of the Test Order screen by double clicking the column he | 926 units | 2016-03-08 |
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.