Acid, Uric, Uricase (Colorimetric)

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Jilin, Shandong and Zhejiang: 6 hold an FDA registration.

Biobase Biodustry(Shandong)Co., Ltd. Shandong
Changchun Merydi BIO-Tech Co., Ltd. Jilin
Changchun Wancheng BIO-Electron Co., Ltd. Jilin, contract manufacturer
Dirui Industrial Co., Ltd. Jilin, contract manufacturer
Hangzhou Lysun Biotechnology Co., Ltd. Zhejiang
Jilin Hongyi BIO-Tech Co., Ltd. Jilin

How Is KNK Classified?

Acid, Uric, Uricase (Colorimetric) is FDA product code KNK, Class 1, 21 CFR 862.1775.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 15 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Device Design (7), Nonconforming Material/Component (1) and Equipment maintenance (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Acid, Uric, Uricase (Colorimetric)

ClearChem Diagnostics Inc. Uric Acid

In Vitro Diagnostics testing kit R1:5X30mL

Acid, Uric, Uricase (Colorimetric)

Dimension Vista® Flex® Reagent Cartridge Urca

Uric Acid Flex® reagent cartridge, 560 tests

Acid, Uric, Uricase (Colorimetric)

MedTest DX Uric Acid for the BS480

For the quantitative determination of Uric Acid in serum using the Mindray BS-480 analyzer. For in vitro diagnostic use only. 4 x 40ml.

Acid, Uric, Uricase (Colorimetric)

Yumizen C1200 Uric Acid

Catalogue number 1300023870, listed by Horiba ABX SAS, France, under Acid, Uric, Uricase (Colorimetric). 6 manufacturers in China are registered for this product code.

Acid, Uric, Uricase (Colorimetric)

Teco Diagnostics TC-Matrix Uric Acid Reagent Kit

Teco Diagnostics TC-Matrix Uric Acid Reagent Kit is intended for the quantitative determination of uric acid in serum or plasma on TC Matrix analyzers.

Acid, Uric, Uricase (Colorimetric)

IDG/Sanzay

For the in vitro quantitative determination of Uric Acid in serum.

Acid, Uric, Uricase (Colorimetric)

Sirrus® Uric Acid LiquiColor®

For the Quantitative Colorimetric Determination of Uric Acid in Serum, Plasma or Urine.

Acid, Uric, Uricase (Colorimetric)

Pointe Uric Acid Reagent

Pointe Uric Acid Reagent packaged for use on the Mindray BA800. 4 x 65ml R1, 3 x 16ml R2. For the quantitative determination of uric acid in serum. For in vitro diagnostic use only.

Acid, Uric, Uricase (Colorimetric)

Teco Diagnostics Uric Acid Liquid Reagent Set

Teco Diagnostics Uric Acid Liquid Reagent Set is used for the quantitative determination of uric acid in serum.

Acid, Uric, Uricase (Colorimetric)

Uric Acid

For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only.

Acid, Uric, Uricase (Colorimetric)

Architect

2 catalogue numbers from 3P39-22, listed by Abbott Medical, United States, under Acid, Uric, Uricase (Colorimetric). 6 manufacturers in China are registered for this product code.

Acid, Uric, Uricase (Colorimetric)

AU

4 catalogue numbers from OSR6698, listed by Beckman Coulter, Inc., United States, under Acid, Uric, Uricase (Colorimetric). 6 manufacturers in China are registered for this product code.

Acid, Uric, Uricase (Colorimetric)

Carolina Liquid Chemistries Corp.® Uric Acid Reagent KIT AU-212

Uric Acid (URIC) Reagent

Acid, Uric, Uricase (Colorimetric)

MedTest DX Uric Acid for the BS200

For the quantitative determination of Uric Acid in serum using the Mindray BS-200 analyzer. For in vitro diagnostic use only. 3 x 40ml.

Acid, Uric, Uricase (Colorimetric)

Uric Reagent Kit

Uric Acid Reagent Kit for use with EasyRA Analyzers

Acid, Uric, Uricase (Colorimetric)

Uric Acid LiquiColor®

Quantitative Enzymatic Colorimetric Determination of Uric Acid in Serum, Plasma or Urine.

Acid, Uric, Uricase (Colorimetric)

Vitros

VITROS Chemistry Products URIC Slides

Acid, Uric, Uricase (Colorimetric)

Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-240

Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-240 is used for the quantitative determination of uric acid in serum or plasma on the TC-Matrix-240 analyzer.

Acid, Uric, Uricase (Colorimetric)

ONE+Step Uric Acid

The one device that has DI number included 5 strips

Acid, Uric, Uricase (Colorimetric)

ABX Pentra Uric Acid CP

Catalogue number 1220001670, listed by Horiba ABX SAS, France, under Acid, Uric, Uricase (Colorimetric). 6 manufacturers in China are registered for this product code.

Acid, Uric, Uricase (Colorimetric)

Synermed®

Uric Acid Reagent 1 X 250 mL + 1 X 100 mL

Acid, Uric, Uricase (Colorimetric)

Advia® Chemistry UA Uric Acid Reagents

Uric Acid - ADVIA Chem. - RGT - 7x140 tests

Acid, Uric, Uricase (Colorimetric)

Architect

Catalogue number 3P39-21, listed by Abbott Laboratories, United States, under Acid, Uric, Uricase (Colorimetric). 6 manufacturers in China are registered for this product code.

Acid, Uric, Uricase (Colorimetric)

Synchron

Uric Acid Reagent (URIC 2 x 300)

Acid, Uric, Uricase (Colorimetric)

Uric Acid (UA)

3 catalogue numbers from UA8333, listed by Randox Laboratories Limited, United Kingdom, under Acid, Uric, Uricase (Colorimetric). 6 manufacturers in China are registered for this product code.

Acid, Uric, Uricase (Colorimetric)

Pointe Scientific, Inc.

Uric Acid Standard intended for use as an uric acid standard for standardization or calibration of uricase / trinder uric acid procedures. Packaged at 1 x 15ml

Acid, Uric, Uricase (Colorimetric)

Uric Acid-SL Assay

2 catalogue numbers from 237-99, listed by Sekisui Diagnostics, LLC, United States, under Acid, Uric, Uricase (Colorimetric). 6 manufacturers in China are registered for this product code.

Acid, Uric, Uricase (Colorimetric)

Alinity

Alinity c Uric Acid Reagent Kit 1200 Tests

Acid, Uric, Uricase (Colorimetric)

Alinity

Uric Acid2 2000 Tests

Acid, Uric, Uricase (Colorimetric)

Teco Diagnostics Uric Acid Reagent Set

Teco Diagnostics Uric Acid Reagent Set is used for the quantitative determination of uric acid in serum.

Acid, Uric, Uricase (Colorimetric)

Advia® Chemistry UA_c Uric Acid Reagents, Concentrated

Uric Acid - ADVIA Chem. - RGT - 6x1250 tests

Acid, Uric, Uricase (Colorimetric)

Uric Acid Assay

Catalogue number SK237-40, listed by Sekisui Diagnostics, LLC, United States, under Acid, Uric, Uricase (Colorimetric). 6 manufacturers in China are registered for this product code.

Acid, Uric, Uricase (Colorimetric)

Atellica CH UA

Uric Acid (UA) Atellica CH - RGT 4800T

Acid, Uric, Uricase (Colorimetric)

Uric Acid Reagent

For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. The determination of uric acid in serum is most commonly performed for the diagnosis of gout.…

Acid, Uric, Uricase (Colorimetric)

Dimension® Flex® Reagent Cartridge Urca

Uric Acid Flex® reagent cartridge, 480 tests

Acid, Uric, Uricase (Colorimetric)

Pointe Scientific, Inc. Uric Acid

Pointe Scientific, Inc. Uric Acid Reagent is for the quantitative determination of Uric Acid in serum. Packaged for use on Olympus Analyzers. For in vitro diagnostic use only. 9 x 65ml, 8 x…

Acid, Uric, Uricase (Colorimetric)

Uric Acid Ver.2

4 catalogue numbers from 04657608190, listed by Roche Diagnostics Gmbh, Germany, under Acid, Uric, Uricase (Colorimetric). 6 manufacturers in China are registered for this product code.

Acid, Uric, Uricase (Colorimetric)

ACE

Uric Acid Reagent

Acid, Uric, Uricase (Colorimetric)

JAS Diagnostics

URIC ACID REAGENT PALS BULK (in 20 dry Liter bottles)

Acid, Uric, Uricase (Colorimetric)

Biobase

18 catalogue numbers from R1:80mL×2 R2:20mL×2, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Acid, Uric, Uricase (Colorimetric). 6 manufacturers in China are registered for this product code.

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