C.f.a.s. PAC
Catalogue number 3555941190, listed by Roche Diagnostics Gmbh, Germany, under Calibrator, Multi-Analyte Mixture. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
14510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | JIX |
| Device type | Calibrator, Multi-Analyte Mixture |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-09-20 |
| Record revised | 2026-02-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3555941190 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 54 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 32 |
| Plasma Calibrator Set | Chromsystems Instruments & Chemicals Gmbh | 22 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 20 |
| Nova | Nova Biomedical Corporation | 15 |
| Plasma Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 15 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 15 |
| Architect | Abbott Laboratories | 11 |
| Alinity | Abbott Medical | 10 |
| Synchron | Beckman Coulter, Inc. | 9 |
| Architect | Abbott Medical | 9 |
| Urine Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 8 |
Showing 12 of 229. All products under Calibrator, Multi-Analyte Mixture
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133330 | 2013-11-26 |
| K103171 | 2011-02-11 |
| K101456 | 2010-09-08 |
| K080607 | 2008-05-12 |
| K062319 | 2006-09-13 |
| K050026 | 2005-01-31 |
| K040264 | 2004-04-02 |
| K040245 | 2004-03-24 |
| K033873 | 2004-02-13 |
| K033501 | 2003-11-20 |
| K031880 | 2003-07-16 |
| K011226 | 2001-06-25 |
| K000576 | 2000-03-21 |
| K990460 | 1999-03-22 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-09-15 | Not classified | Package design/selection | Test results, low: Sodium, potassium and chloride results on the cobas 6000 ISE unit may exhibit a downward drift in controls and patient samples within the recommended calibration interval of 24 hours. For further information, please cont | 7909 | 2009-12-01 |
| 2007-11-14 | Not classified | Process design | High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay. | 1,904 | 2009-09-22 |
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.