ACE Kinetic Kit
The BÜHLMANN ACE kinetic test is intended for the direct and quantitative in vitro diagnostic determination of angiotensin converting enzyme (ACE) activity in serum by an enzymatic assay.
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| 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 |
| 510(k) | K913091 |
| Record published | 2016-09-01 |
| Record revised | 2025-06-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2025-06-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KK-ACKX | In distribution | |
| KK-ACK4 | In distribution | |
| KK-ACK2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 5 |
| ACE Reagent | Sentinel CH. SPA | 2 |
| Bühlmann ACE Kinetic | Bühlmann Laboratories AG | 1 |
| ACE Liquid | Sentinel CH. SPA | 1 |
| ACE Kinetik Kit | Bühlmann Laboratories AG | 1 |
| Trinity Biotech | Trinity Biotech Public Limited Company | 1 |
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.