Bühlmann ACE Kinetic

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…

Registry build 21.09.26

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.

1manufacturer
1catalogue number

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code KQN
Manufacturer City Province Registered as Device types
Biobase Biodustry(Shandong)Co., Ltd. Jinan Shandong Manufacturer 70

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

Catalogue Numbers

Catalogue numbers for Bühlmann ACE Kinetic
Catalogue number Size Status
KK-ACK2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Biobase Biobase Biodustry(Shandong)Co., Ltd. 5
ACE Kinetic Kit Bühlmann Laboratories AG 3
ACE Reagent Sentinel CH. SPA 2
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer