The ACE Reagent is an automated assay intended for in vitro diagnostic use in the quantitative determination of angiotensin converting enzyme (ACE) activity in human serum or plasma on the…
The ACE Reagent is an automated assay intended for in vitro diagnostic use in the quantitative determination of angiotensin converting enzyme (ACE) activity in human serum or plasma on the ARCHITECT c System.This test is used as an aid in the diagnosis of pulmonary sarcoidosis and other pathologic conditions involving lung and liver diseases. For laboratory professional use only.
Who Else Makes It
Registered in Shandong.
Record
Regulatory record for ACE Reagent | Listed by | Sentinel CH. SPA, Italy |
| FDA product code | KQN |
| Device type | Radioassay, Angiotensin Converting Enzyme |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1090 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-01-27 |
Specifications
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 | Special storage condition: Store between 2 and 8 degrees Celsius |
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.