Inorganic Phosphorous (Phos)
An inorganic phosphorous test system is a device intended for the quantitative in vitro determination of inorganic phosphorous concentration in serum and urine.
2manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | CEO |
| Device type | Phosphomolybdate (Colorimetric), Inorganic Phosphorus |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1580 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-03 |
| Record revised | 2023-07-06 (version 2) |
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 |
| Storage | Storage environment temperature 15 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PH8048 | In distribution | |
| PH3872 | In distribution | |
| PH8328 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 13 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| Pointe Scientific, Inc. Phosphorus | Horiba Instruments Incorporated | 6 |
| Carolina Liquid Chemistries Corp.® Phosphorus Reagent KIT AU-218 | Carolina Liquid Chemistries | 5 |
| JAS Diagnostics | Drew Scientific, Ltd. | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 4 |
| Phosphate (Inorganic) ver.2 | Roche Diagnostics Gmbh | 3 |
| Pointe Phosphorus Reagent | Horiba Instruments Incorporated | 2 |
| Architect | Abbott Medical | 2 |
| Architect | Abbott Laboratories | 2 |
| Architect | Abbott Ireland | 2 |
| Advia® Chemistry IP Inorganic Phosphorus Reagents | Siemens Healthcare Diagnostics Inc | 2 |
Showing 12 of 40. All products under Phosphomolybdate (Colorimetric), Inorganic Phosphorus
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K974605 | 1998-01-09 |
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.