HR Series NEFA-HR(2) Color Reagent B

Catalogue number 991-34891, listed by Fujifilm Wako Pure Chemical Corporation, under Titrimetric, Fatty Acids. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26
2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jilin (1), Yunnan (1).

Chinese manufacturers registered for FDA product code JLH
Manufacturer City Province Registered as Device types
Dirui Industrial Co., Ltd. Changchun Jilin Contract manufacturer 84
Kunming Lianen Biotechnology Co., Ltd. Kunming Yunnan Manufacturer 4

Record

Regulatory record for HR Series NEFA-HR(2) Color Reagent B
Listed by Fujifilm Wako Pure Chemical Corporation
FDA product code JLH
Device type Titrimetric, Fatty Acids
Device class Class 1
Regulation 21 CFR 862.1290
Premarket notification Exempt
Record published 2021-06-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature 2 to 10 °C

Catalogue Numbers

Catalogue numbers for HR Series NEFA-HR(2) Color Reagent B
Catalogue number Size Per pack Status
991-34891 4 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Lookee® AscleTrack™ Heart-type Fatty Acid-Binding Protein (H-Fabp) Test Strip Kunming Lianen Biotechnology Co., Ltd. 1
HR Series NEFA-HR(2) Color Reagent A Fujifilm Wako Pure Chemical Corporation 1
HR Series NEFA-HR(2) Solvent A Fujifilm Wako Pure Chemical Corporation 1
HR Series NEFA-HR(2) Solvent B Fujifilm Wako Pure Chemical Corporation 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