Architect
Phosphorus
2manufacturers in China registered for this device type
2catalogue numbers in this listing
4510(k) clearances naming this product code
3recalls on this code
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 | Abbott Laboratories, United States |
|---|---|
| FDA product code | CEO |
| Device type | Phosphomolybdate (Colorimetric), Inorganic Phosphorus |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1580 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-09 |
| Record revised | 2024-02-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Handling environment temperature up to 29 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7D71-31 | In distribution | |
| 7D71-22 | 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 |
| Inorganic Phosphorous (Phos) | Randox Laboratories Limited | 3 |
| Pointe Phosphorus Reagent | Horiba Instruments Incorporated | 2 |
| Architect | Abbott Medical | 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 |
|---|---|
| K981759 | 1998-06-16 |
| K981118 | 1998-06-12 |
| K863088 | 1986-09-25 |
| K781000 | 1978-12-04 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-08-12 | Class II | Error in labeling | Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier. | 7213 | 2015-04-06 |
| 2010-05-04 | Not classified | Other | Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure. | 3136 | 2012-04-05 |
| 2007-01-30 | Not classified | Other | Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus greater than 80.0 mg/dL (25.80 mmol/L) | 42020HW00 – 1,351 units worldwide; 44037HW00 – 314 units wor | 2011-08-10 |
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.