Enzymatic Method, Creatinine

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Chongqing, Guangdong and Guangxi, and 1 other province: 4 hold an FDA registration. 2 are contract manufacturers.

Acon Biotech (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
Chong Qing Teco Huayi Pharm. Co. Chongqing, contract manufacturer
Dongguan Honfield Precision Parts Co., Ltd. Guangdong, contract manufacturer
Urit Medical Electronic Co., Ltd. Guangxi, contract manufacturer

How Is JFY Classified?

Enzymatic Method, Creatinine is FDA product code JFY, Class 2, 21 CFR 862.1225.

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

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 29 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Device Design (11), Labeling Change Control (3) and Nonconforming Material/Component (2).

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

Enzymatic Method, Creatinine

Alere Afinion™ ACR

Albumin/Creatinine Ratio test kit. Intended use: For the determination of albumin, creatinine and the albumin/creatinine ratio in human urine. Contents: 15 Test Cartridges. 1 Package…

Enzymatic Method, Creatinine

Dimension Vista® Flex® Reagent Cartridge Ecrea

Enzymatic Creatinine Flex® reagent cartridge, 800 Tests

Enzymatic Method, Creatinine

Sirrus® Creatinine LiquiColor®

For the Quantitative Determination of Creatinine in Serum and Urine.

Enzymatic Method, Creatinine

Synchron

Enzymatic Creatinine Reagent (CR-E 2 x 200)

Enzymatic Method, Creatinine

ABX Pentra Enzymatic Creatinine CP

ABX Pentra Enzymatic Creatinine CP is a laboratory reagent for measuring creatinine in human serum, plasma and urine. It is used with associated calibrator and control materials on the ABX…

Enzymatic Method, Creatinine

Pointe Creatinine, Enzymatic Reagent

Pointe Creatinine, Enzymatic Reagent packaged for use on the Mindray BA800. 3 x 60ml R1, 3 x 20ml R2. For the quantitative determination of C-reactive protein in serum or plasma by latex…

Enzymatic Method, Creatinine

Clinistix Kidney Health Test System

Test Strips for the Determination of Albumin and Creatinine in Urine

Enzymatic Method, Creatinine

Enzymatic Creatinine Assay

Catalogue number 265-30, listed by Sekisui Diagnostics, LLC, United States, under Enzymatic Method, Creatinine. 4 manufacturers in China are registered for this product code.

Enzymatic Method, Creatinine

Automatic Urine Analyzer

2 catalogue numbers from UC-1800, listed by Urit Medical Electronic Co., Ltd., China, under Enzymatic Method, Creatinine. 4 manufacturers in China are registered for this product code.

Enzymatic Method, Creatinine

Creatinine (Enzymatic)

Catalogue number SK265-20, listed by Sekisui Diagnostics, LLC, United States, under Enzymatic Method, Creatinine. 4 manufacturers in China are registered for this product code.

Enzymatic Method, Creatinine

Yumizen C1200 Creatinine PAP

Yumizen C1200 Creatinine PAP 1300023844 : R1 ( 4x46 mL ; R2 3x34 mL) 1300023843 : R1 ( 6x35 mL ; R2 6x19 mL)

Enzymatic Method, Creatinine

Clinitek Status®+ Analyzer

The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest®…

Enzymatic Method, Creatinine

Crea Reagent Kit

Creatinine Reagent Kit for use with EasyRA Analyzers

Enzymatic Method, Creatinine

Creatinine Enzymatic

For the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only.

Enzymatic Method, Creatinine

Creatine Kinase

Catalogue number 5168546190, listed by Roche Diagnostics Gmbh, Germany, under Enzymatic Method, Creatinine. 4 manufacturers in China are registered for this product code.

Enzymatic Method, Creatinine

Atellica CH ECre_2

Enzymatic Creatinine ( Ecrea_2) Atellica CH - RGT 1400T

Enzymatic Method, Creatinine

Advia® Chemistry ECRE_2 Creatinine_2 Reagents (Enzymatic)

Creatinine enzymatic - ADVIA Chem. - RGT - 4x350 tests

Enzymatic Method, Creatinine

Carolina Liquid Chemistries Corp.® CLC720 Creatinine Reagent KIT

CREA (Creatinine) 4 x 250 tests

Enzymatic Method, Creatinine

Vitros

VITROS Chemistry Products CREA Slides

Enzymatic Method, Creatinine

Multistix® Reagent Strips

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, glucose, ketone (acetoacetic acid), pH, bilirubin and urobilinogen.

Enzymatic Method, Creatinine

Creatinine Plus Ver2

3 catalogue numbers from 5168589190, listed by Roche Diagnostics Gmbh, Germany, under Enzymatic Method, Creatinine. 4 manufacturers in China are registered for this product code.

Enzymatic Method, Creatinine

Urine Reagent Strips

Catalogue number URIT 11FA,100 pcs/tube, listed by Urit Medical Electronic Co., Ltd., China, under Enzymatic Method, Creatinine. 4 manufacturers in China are registered for this product code.

Enzymatic Method, Creatinine

Fully-Automated Urine Chemistry Analyzer

Catalogue number DxU 1800c,1 unit, listed by Urit Medical Electronic Co., Ltd., China, under Enzymatic Method, Creatinine. 4 manufacturers in China are registered for this product code.

Enzymatic Method, Creatinine

Carolina Liquid Chemistries Corp.® Ucrea RGT. KIT BL-343

CREAu (Creatinine, Urine) only

Enzymatic Method, Creatinine

PTS Panels® Creatinine Test Strips

PTS Panels® Creatinine test strips are in vitro diagnostic devices used to monitor creatinine levels in human whole blood. These test strips must be used in conjunction with a CardioChek®…

Enzymatic Method, Creatinine

Pointe Creatinine Enzymatic on BS480

Pointe Creatinine Enzymatic Reagent packaged for use on the BS480. 4x40mL, 4x14mL Kit. For the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic…

Enzymatic Method, Creatinine

Atellica CH ECRE3

Atellica CH Enzymatic Creatinine 3 measures creatinine in human serum, urine and lithium-heparin or dipotassium-EDTA plasma. The in vitro diagnostic assay runs on the Atellica CH Analyzer.…

Enzymatic Method, Creatinine

Afinion HbA1c

Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood. Contents: 15 test cartridges, 1 package insert

Enzymatic Method, Creatinine

Advia Chem Ecre3

Creatinine enzymatic - ADVIA Chem. - RGT

Enzymatic Method, Creatinine

Pointe Scientific, Inc. Creatinine Enzymatic

Creatinine Enzymatic Reagent, For the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only. Size: 6 x 60ml, 6 x 20ml

Enzymatic Method, Creatinine

Creatinine LiquiColor®

For the quantitative enzymatic determination of creatinine in serum and urine.

Enzymatic Method, Creatinine

Pointe Scientific, Inc.

Creatinine Enzymatic Reagent, for the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only. Size: 3 x 120 mL, 1 x 120 mL

Enzymatic Method, Creatinine

Afinion ACR

Albumin/Creatinine ration test kit. Intended use: For the determination of albumin, creatinine and albumin/creatinine ration in human urine. Contetns: 15 test cartridges. 1 package insert.

Enzymatic Method, Creatinine

Alinity

Alinity c Creatinine (Enzymatic) Reagent Kit 3600 Tests

Enzymatic Method, Creatinine

CR Cartridge

CR Cartridge, 25 count

Enzymatic Method, Creatinine

Clinitek® Microalbumin 2 Reagent Strips

CLINITEK® Microalbumin 2 Reagent Strips are firm plastic strips that contain two reagent pads that test for albumin and creatinine in urine.

Enzymatic Method, Creatinine

Teco Diagnostics

URS-2M-25 Generic Finished KIT

Enzymatic Method, Creatinine

Dimension® Flex® Reagent Cartridge Ezcr

Enzymatic Creatinine Flex® reagent cartridge, 448 tests

Enzymatic Method, Creatinine

Creatinine Plus

3 catalogue numbers from 11875566216, listed by Roche Diagnostics Gmbh, Germany, under Enzymatic Method, Creatinine. 4 manufacturers in China are registered for this product code.

Enzymatic Method, Creatinine

Creatinine Plus Ver.2

Catalogue number 08057524190, listed by Roche Diagnostics Gmbh, Germany, under Enzymatic Method, Creatinine. 4 manufacturers in China are registered for this product code.

Enzymatic Method, Creatinine

Architect

Creatinine (Enzymatic)

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