Trinity Biotech

ACE Reagent

Registry build 21.09.26
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 Trinity Biotech
Listed by Trinity Biotech Public Limited Company
FDA product code KQN
Device type Radioassay, Angiotensin Converting Enzyme
Device class Class 2
Regulation 21 CFR 862.1090
510(k) K854245
Record published 2016-09-23
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, expiry date
Storage Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Trinity Biotech
Catalogue number Size Status
305-10 10 x 10 mL 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
Bühlmann ACE Kinetic Bühlmann Laboratories AG 1
ACE Liquid Sentinel CH. SPA 1
ACE Kinetik Kit Bühlmann Laboratories AG 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