CalCheck Vitamin D Total III
Vitamin D total G3 CC 5 Elecsys
12manufacturers in China registered for this device type
1catalogue number
60510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jilin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Guangdong Transtek Medical Electronics Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 11 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| BD Rapid Diagnostics (Suzhou) Co., Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area | Manufacturer | 6 | |
| Sejoy Biomedical Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 5 |
| Beijing Genesee Biotech, Inc. | Beijing | Beijing | Manufacturer | 4 |
| Human Metabolomics Institute, Inc. | Shenzhen | Guangdong | Manufacturer | 4 |
| Changsha Sinocare Inc. | Changsha | Hunan | Manufacturer | 2 |
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | JJX |
| Device type | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-12-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09108912190 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 55 |
| Validate | LGC Clinical Diagnostics, Inc. | 37 |
| Architect | Abbott Laboratories | 24 |
| Architect | Abbott Medical | 23 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 22 |
| Architect | Abbott Ireland | 18 |
| Liquichek | Bio-Rad Laboratories Inc. | 17 |
| Alinity | Abbott Medical | 17 |
| Alinity | Abbott Ireland | 15 |
| Fora | Fora Care Inc. | 15 |
| Pregnancy-Skreen | Biochemical Diagnostics, Inc. | 14 |
| Accurun® | LGC Clinical Diagnostics, Inc. | 14 |
Showing 12 of 907. All products under Single (Specified) Analyte Controls (Assayed And Unassayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170678 | 2017-04-04 |
| K162173 | 2017-01-12 |
| K150955 | 2015-05-01 |
| K143284 | 2014-12-16 |
| K142127 | 2014-09-05 |
| K140534 | 2014-03-27 |
| K133284 | 2013-11-22 |
| K122242 | 2012-12-05 |
| K121895 | 2012-08-24 |
| K121279 | 2012-05-10 |
| K112528 | 2011-10-18 |
| K112113 | 2011-09-14 |
| K112104 | 2011-08-25 |
| K111552 | 2011-07-21 |
| K111349 | 2011-06-09 |
| K110613 | 2011-05-12 |
| K103402 | 2011-01-07 |
| K103099 | 2010-12-06 |
| K103162 | 2010-11-18 |
| K102086 | 2010-11-01 |
| K102269 | 2010-10-07 |
| K101365 | 2010-10-05 |
| K101856 | 2010-10-05 |
| K102267 | 2010-09-10 |
| K102044 | 2010-08-31 |
| K101075 | 2010-06-11 |
| K094031 | 2010-04-27 |
| K100810 | 2010-04-26 |
| K093836 | 2010-04-15 |
| K100594 | 2010-04-01 |
| K093582 | 2010-03-29 |
| K092848 | 2010-03-19 |
| K093700 | 2010-03-04 |
| K092169 | 2009-12-16 |
| K092168 | 2009-11-16 |
| K092888 | 2009-11-10 |
| K092585 | 2009-10-30 |
| K091601 | 2009-09-25 |
| K090311 | 2009-05-05 |
| K083655 | 2009-02-12 |
| K080643 | 2008-08-22 |
| K080147 | 2008-02-27 |
| K062972 | 2006-10-13 |
| K053059 | 2005-11-28 |
| K043320 | 2004-12-17 |
| K040157 | 2004-02-25 |
| K031990 | 2003-08-20 |
| K031698 | 2003-08-20 |
| K020883 | 2002-11-29 |
| K020369 | 2002-03-06 |
| K010237 | 2001-02-14 |
| K003967 | 2001-01-12 |
| K003772 | 2000-12-20 |
| K001846 | 2000-06-28 |
| K001014 | 2000-06-01 |
| K001015 | 2000-04-27 |
| K000042 | 2000-03-17 |
| K993642 | 1999-11-30 |
| K981281 | 1998-04-24 |
| K981278 | 1998-04-23 |
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.