The BÜHLMANN ACE kinetic assay is intended for the direct and quantitative in vitro diagnostic determination of angiotensin converting enzyme (ACE) activity in serum samples by enzymatic…
The BÜHLMANN ACE kinetic assay is intended for the direct and quantitative in vitro diagnostic determination of angiotensin converting enzyme (ACE) activity in serum samples by enzymatic assay.
Who Else Makes It
Registered in Shandong.
Record
Regulatory record for Bühlmann ACE Kinetic | Listed by | Bühlmann Laboratories AG, Switzerland |
| FDA product code | KQN |
| Device type | Radioassay, Angiotensin Converting Enzyme |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1090 |
| Premarket notification | Exempt |
| Record published | 2025-06-27 |
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 | Storage environment temperature 2 to 8 °C |
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.