Reagent Kit

HPLC Reagent Kit, Serotonin in serum/plasma/whole blood

Registry build 21.09.26
1manufacturer
3catalogue numbers in this listing

Who Else Makes It

Registered in Hubei. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code CDA
Manufacturer City Province Registered as Device types
Wuhan Chenkang Science Technology Co., Ltd. Wuhan Hubei Contract manufacturer 1

Record

Regulatory record for Reagent Kit
Listed by Chromsystems Instruments & Chemicals Gmbh, Germany
FDA product code CDA
Device type Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
Device class Class 1
Regulation 21 CFR 862.1390
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2020-08-27

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, expiry date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Reagent Kit
Catalogue number Size Status
51000 100 analyses In distribution
3030 100 analyses In distribution
4000 100 analyses In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Reagent Chromsystems Instruments & Chemicals Gmbh 11
Serotonin Elisa DRG International, Inc. 1
Serotonin Elisa DRG Instruments Gesellschaft mit beschränkter Haftung 1
Accessorie Chromsystems Instruments & Chemicals Gmbh 1
5-HIAA Elisa DRG Instruments Gesellschaft mit beschränkter Haftung 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