Stat Profile
Stat Profile pHOx Ultra/CCX Co-ox Calibrator Cartridge with Bilirubin and Deproteinizing Solution
3manufacturers in China registered for this device type
54catalogue numbers in this listing
2510(k) clearances naming this product 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 | Nova Biomedical Corporation, United States |
|---|---|
| FDA product code | JIX |
| Device type | Calibrator, Multi-Analyte Mixture |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K110648 |
| Record published | 2016-09-20 |
| Record revised | 2018-07-06 (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, manufacturing date, serial number |
| Storage | Handling environment temperature 15 to 30 °C; Storage environment temperature 15 to 30 °C |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PHOX ULTRA/CCX | In distribution | ||
| PHOX ULTRA/CCX | In distribution | ||
| PHOX PLUS | In distribution | ||
| PRIME ABG | In distribution | ||
| PHOX ULTRA/CCX | In distribution | ||
| PRIME CCS | In distribution | ||
| PRIME ABG | In distribution | ||
| PHOX BASIC | In distribution | ||
| PHOX PLUS | In distribution | ||
| phox basic | In distribution | ||
| CCX | In distribution | ||
| PRIME ABG | In distribution | ||
| PHOX PLUS C | In distribution | ||
| PRIME CCS | In distribution | ||
| PHOX PLUS L | In distribution | ||
| CCX | In distribution | ||
| PHOX PLUS L | In distribution | ||
| phox/ccx | 20 | In distribution | |
| PRIME ABG | In distribution | ||
| PHOX PLUS C | In distribution | ||
| PRIME CCS | In distribution | ||
| PRIME CCS | In distribution | ||
| PRIME CCS | In distribution | ||
| CCX CO-OX | In distribution | ||
| PHOX ULTRA/CCX | In distribution | ||
| PRIME CCS | In distribution | ||
| CCX | In distribution | ||
| PHOX/BASIC | In distribution | ||
| PRIME CCS | In distribution | ||
| PHOX PLUS C | In distribution | ||
| 1 | In distribution | ||
| PHOX/BASIC | In distribution | ||
| PHOX ULTRA/CCX | In distribution | ||
| PHOX ULTRA/CCX | In distribution | ||
| PHOX PLUS L | In distribution | ||
| PRIME | In distribution | ||
| PHOX ULTRA/CCX | In distribution | ||
| PHOX/BASIC | In distribution | ||
| PRIME ABG | In distribution | ||
| PHOX PLUS | In distribution | ||
| CCX | In distribution | ||
| phox Ultra/CCX Co-Ox | In distribution | ||
| PHOX PLUS L | In distribution | ||
| phox Ultra/CCX Co-Ox | In distribution | ||
| pHOx Ultra/CCX | 250 | In distribution | |
| PHOX | In distribution | ||
| PHOX PLUS | In distribution | ||
| CCX | In distribution | ||
| PHOX ULTRA/CCX | In distribution | ||
| PHOX ULTRA/CCX | In distribution | ||
| PHOX | In distribution | ||
| PHOX | In distribution | ||
| PRIME CCS | In distribution | ||
| PRIME CCS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Serum Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 8 |
Showing 12 of 229. All products under Calibrator, Multi-Analyte Mixture
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K897177 | 1990-03-27 |
| K841464 | 1984-06-22 |
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.