Stat Profile
Stat Profile pHOx Ultra/CCX Chemistry Controls Auto-Cartridge with Creat 6/Day
1manufacturer
38catalogue numbers in this listing
8510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Nova Biomedical Corporation, United States |
|---|---|
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K002613 |
| 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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 24 to 26 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PHOX PLUS/C | In distribution | ||
| PHOX PLUS L | In distribution | ||
| PHOX PLUS/C | In distribution | ||
| PHOX ULTRA/CCX | In distribution | ||
| PRIME CCS | In distribution | ||
| phox ultra/ccx | 30 | In distribution | |
| PRIME ABG | In distribution | ||
| CCX | In distribution | ||
| PHOX PLUS L | In distribution | ||
| PHOX PLUS/C | In distribution | ||
| pHOx/BASIC/PLUS/L/C | In distribution | ||
| PHOX ULTRA/CCX | In distribution | ||
| PHOX/BASIC | In distribution | ||
| PRIME CCS | In distribution | ||
| PHOX | 20 | In distribution | |
| PRIME ABG | In distribution | ||
| Prime ABG/CCS | 30 | In distribution | |
| phox ultra/ccx | 20 | In distribution | |
| phox plus L | 30 | In distribution | |
| PHOX ULTRA/CCX | In distribution | ||
| PHOX PLUS L | In distribution | ||
| PHOX PLUS L | In distribution | ||
| PHOX ULTRA/CCX | In distribution | ||
| phox plus/c | 30 | In distribution | |
| PHOX ULTRA/CCX | In distribution | ||
| CCX | 30 | In distribution | |
| phox/basic | 30 | In distribution | |
| PHOX ULTRA/CCX | In distribution | ||
| PHOX/BASIC | In distribution | ||
| PHOX ULTRA/CCX | In distribution | ||
| PHOX/BASIC | In distribution | ||
| PRIME CCS | In distribution | ||
| CCX | 30 | In distribution | |
| PHOX/BASIC | In distribution | ||
| PRIME ABG | In distribution | ||
| phox ultra/ccx | 30 | In distribution | |
| PHOX ULTRA/CCX | In distribution | ||
| PHOX PLUS/C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Liquichek | Bio-Rad Laboratories Inc. | 154 |
| Validate | LGC Clinical Diagnostics, Inc. | 120 |
| InteliQ | Bio-Rad Laboratories Inc. | 50 |
| Lyphochek | Bio-Rad Laboratories Inc. | 39 |
| i-STAT | Abbott Point OF Care Inc. | 24 |
| Multichem AE | Techno-Path Manufacturing Ltd. | 20 |
| Serum Control | Chromsystems Instruments & Chemicals Gmbh | 18 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 16 |
| Nova | Nova Biomedical Corporation | 14 |
| Plasma Control | Chromsystems Instruments & Chemicals Gmbh | 14 |
| Multichem IA Speciality | Techno-Path Manufacturing Ltd. | 12 |
| Rap/Tac/CsA Control | More Diagnostics Inc. | 12 |
Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101633 | 2010-08-27 |
| K962982 | 1996-08-23 |
| K962997 | 1996-08-15 |
| K955264 | 1996-02-02 |
| K955252 | 1996-02-02 |
| K955260 | 1996-02-02 |
| K931373 | 1993-06-15 |
| K841452 | 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.