Indicator Method, Protein or Albumin (Urinary, Non-Quant.)

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Jilin, Zhejiang and Chongqing, and 5 other provinces: 14 hold an FDA registration. 5 are contract manufacturers.

Acon Biotech (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
AVE Science & Technology Co., Ltd. Hunan
Changchun Merydi BIO-Tech Co., Ltd. Jilin
Changchun Wancheng BIO-Electron Co., Ltd. Jilin, contract manufacturer
Changchun LYZ Technology Co., Ltd. Jilin
Chong Qing Teco Huayi Pharm. Co. Chongqing, contract manufacturer
Dirui Industrial Co., Ltd. Jilin, contract manufacturer
Dongguan Honfield Precision Parts Co., Ltd. Guangdong, contract manufacturer
Jilin Hongyi BIO-Tech Co., Ltd. Jilin
Jilin Test BIO-Electron Co., Ltd. Jilin
Kunming Lianen Biotechnology Co., Ltd. Yunnan
Urit Medical Electronic Co., Ltd. Guangxi, contract manufacturer
Weihai Kangzheng Medical Equipments Technology Co., Ltd. Shandong, contract manufacturer
Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer

What Is FDA Product Code JIR?

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) is FDA product code JIR, Class 1, 21 CFR 862.1645.

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 7 recalls under this product code since 2024. 1 was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (3) and No Marketing Application (2).

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

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Tinaquant Albumin Gen2

Catalogue number 4469658190, listed by Roche Diagnostics Gmbh, Germany, under Indicator Method, Protein Or Albumin (Urinary, Non-Quant.). 14 manufacturers in China are registered for this product code.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System

Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System is an in vitro diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It…

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Atellica CH uALB_2

Microalbumin (µALB_2) Atellica CH - RGT 840T

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

DCA Vantage® Analyzer

The DCA Vantage system is a semi-automated, benchtop system. It is designed to quantitatively measure the percent of Hemoglobin A1cin blood and low concentrations of albumin in urine…

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Advia® Chemistry µALB Microalbumin Reagents

Microalbumin - ADVIA Chem. - RGT - 4x105/4x130 tests

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Lookee® AscleTrack™ Urine Microalbumin (MAU) Test Strip

Catalogue number A802, listed by Kunming Lianen Biotechnology Co., Ltd., China, under Indicator Method, Protein Or Albumin (Urinary, Non-Quant.). 14 manufacturers in China are registered for this product code.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

InstaTest

InstaTest URS-1P is intended semi-quantitative and qualitative detection of protein in urine.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

QMedix™

QMedix™ URS-1P is intended semi-quantitative and qualitative detection of protein in urine.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

URiSCAN 2 ACR Strip

Urinalysis dip and read strips for URiSCAN urine analyzer. Test for Microalbumin and Creatinine in urine.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Detector UA 10SG

For rapid detection of multiple analytes in human urine.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Clinitek Novus® Automated Urine Chemistry Analyzer

The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens…

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Micro-Albumin Elisa

Micro-Albumin ELISA is a competitive test system for the quantitative measurement of human albumin in urine.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Urine Strips

Catalogue number UrineRS-13, listed by Urit Medical Electronic Co., Ltd., China, under Indicator Method, Protein Or Albumin (Urinary, Non-Quant.). 14 manufacturers in China are registered for this product code.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Tina-Quant Albumin Gen.2

Catalogue number 08056722190, listed by Roche Diagnostics Gmbh, Germany, under Indicator Method, Protein Or Albumin (Urinary, Non-Quant.). 14 manufacturers in China are registered for this product code.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Micro-Albumin Elisa

Micro-Albumin ELISA is a competitive test system for the quantitative measurement of human albumin in urine.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

One+Step Protein

100strip/1 bottle

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Cardinal Health

2 ACR Urine Strip Microalbumin Creatinine For Urine

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Tinaquant Albumin

2 catalogue numbers from 4999622190, listed by Roche Diagnostics Gmbh, Germany, under Indicator Method, Protein Or Albumin (Urinary, Non-Quant.). 14 manufacturers in China are registered for this product code.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Medline

STRIPS,URINE,REAGENT,4OB,100 Strips/BT

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Total Protein (UP)

For the quantitative in vitro determination of total protein in urine and C.S.F.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

DCA™ Systems Microalbumin Creatinine Reagent Kit

DCA Microablumin Creatinine Test Kit (ACR test).

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System

Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System consists of the Uritek TC-720+ Urine Analyzer and the Teco Diagnostics Urine Reagent Strips (URS-10). The Uritek TC-720+ Urine…

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Micro-Albumin

Micro-Albumin is a competitive ELISA test system for the quantitative measurement of human albumin in urine. This product is intended for professional in vitro diagnostic use only. The rate…

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Detector UA 2

Catalogue number IDU-2PG, listed by Immunostics, Inc., United States, under Indicator Method, Protein Or Albumin (Urinary, Non-Quant.). 14 manufacturers in China are registered for this product code.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Henry Schein

Urispec 4-Way

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

DCA 2000® Microalbumin Creatinine Control Kit

The DCA Microalbumin Creatinine Control Kit contains both Low Controls and High Controls. Each control is a buffered aqueous solution containing known amounts of human albumin and…

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Rapid Response

Rapid Response 4 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocytes, Protein in…

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

DCA® Systems Microalbumin/Creatinine Capillary Holders and Plungers

A urine collection tube holder and plunger; to be used with DCA® Systems Microalbumin/Creatinine Reagent Cartridge.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Teco Diagnostics

URS-11 100 Strips Generic Finished Kit

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Minuteful – Kidney Test

Minuteful - kidney test is a prescription home urine test for people at risk of kidney disease. It measures albumin and creatinine semiquantitatively and presents their…

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Accutest

2 Parameter Urine Reagent Strip (Glucose, Protein)

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Uri-Trak 120 M Urine Analyzer

The Uri-Trak® 120 M Urine Analyzer is intended for use in conjunction with the Uri-Chek® 10SG Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in…

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Micro Protein (CSF/Urine) LiquiColor®

For the Quantitative Colorimetric Determination of Total Protein in Urine or Cerebrospinal Fluid.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Cybow P

2 catalogue numbers from 0143, listed by DFI Co., Ltd., South Korea, under Indicator Method, Protein Or Albumin (Urinary, Non-Quant.). 14 manufacturers in China are registered for this product code.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Chemstrip Micral Urine Test Strips

Catalogue number 11544039160, listed by Roche Diagnostics Gmbh, Germany, under Indicator Method, Protein Or Albumin (Urinary, Non-Quant.). 14 manufacturers in China are registered for this product code.

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Multistix® 9 SG Reagent Strips

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH, specific gravity and…

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Mission Urinalysis Reagent Strips

Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT)

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