Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Which Manufacturers in China Make This?

3 of the 5 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Zhejiang, Chongqing and Guangxi, and 1 other province.

Acon Biotech (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
Chong Qing Teco Huayi Pharm. Co. Chongqing, contract manufacturer
Dirui Industrial Co., Ltd. Jilin, contract manufacturer
Urit Medical Electronic Co., Ltd. Guangxi, contract manufacturer
Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer

How Is JIL Classified?

Method, Enzymatic, Glucose (Urinary, Non-Quantitative) is FDA product code JIL, Class 2, 21 CFR 862.1340.

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 Do the Recalls Say?

The FDA has recorded 7 recalls under this product code since 2014. None was by a company in China. The root causes the FDA records most often are Process control (3), Nonconforming Material/Component (1) and Device Design (1).

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

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Yodoc 10

The one device that DI number included 100 strips

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

QMedix™

QMedix™URS-10 InstaTest is intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period of time.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Chemstrip 2 GP Urine Test Strips

Catalogue number 11895362160, listed by Roche Diagnostics Gmbh, Germany, under Method, Enzymatic, Glucose (Urinary, Non-Quantitative). 5 manufacturers in China are registered for this product code.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

URiSCAN 1 Glucose Strip

Urinalysis dip and read strips for visual. Test for Glucose in urine.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Cobas U Pack

The cobas u pack is a cassette of urine test strips for use with the cobas u 601 urine analyzer. It supports qualitative or semiquantitative measurement of ten urine characteristics,…

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Combistix® Reagent Strips

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, glucose and pH.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

URiSCAN 10 SGL Strip

Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Ketones(Acetoacetic Acid), Protein, Nitrite, Glucose, pH, SG(Specific Gravity)…

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Diastix®

Reagent strips for urinalysis - glucose. 100 test strips.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

URiSCAN 2 GP Strip

Urinalysis dip and read strips for visual. Test for Protein and Glucose in urine.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Accustrip Urine Reagent Strip Reader

Urine Reagent Strip Reader For Use With Accustrip URS 10 Urine Reagent Strips. *CLIA-Waived*

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Detector UA 2GP

For rapid detection of multiple analytes in human urine.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

URiSCAN 6 L Strip

Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Blood, Protein, Nitrite, Glucose, pH and Leucocytes in urine.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Vchem®

vChem®10 SG Urine Chemistry Strips

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Clinitek Novus® 10 Urinalysis Cassette 450

Cassette to be used on the CLINITEK Novus system for determination of 10 parameters. 450 tests guaranteed per cassette

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Henry Schein

Urispec Pro 5OB Urine Strip

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Aimstrip US-2

Dipstick reagent strips for the qualitative detection of Glucose & Protein in urine.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Aution MAX™ AX-4060 Analyzer

The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative…

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Urine Reagent Strips, 1-Parameter, Glucose

Urine reagent strips; 1-parameter; glucose; 100 strips per vial

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Medline

Reader,barcode,for Medline 120 Analyzer

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

McKesson

Cable, Data Transfer F/Analyze

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Uristix® 4 Reagent Strips

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, leukocytes, nitrite, glucose.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Clinitek Novus® Rinse Additive

Rinse additive for CLINITEK Novus® automated urine chemistry system.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Rapid Response

Rapid Response 2 Parameter Urinalysis Reagent Strips (Glu/Pro) - 100 tests/ kit are for the qualitative or semi-quantitative detection of Glucose and Protein in urine.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Albustix® Reagent Strips

ALBUSTIX® are intended for in vitro diagnostic use by healthcare professionals to detect the presence of protein in urine.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Multistix® 10 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, bilirubin…

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Mission Urinalysis Reagent Strips

Mission Urinalysis Reagent Strips (GLU/KET/PRO/PH/BLO/NIT/LEU)

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Teco Diagnostics Urine Reagent Strips (URS-1G)

Teco Diagnostics Urine Reagent Strips (URS-1G) are for in vitro semi-quantitative detection of glucose in urine. The URS-1G strips are for professional use only.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

InstaTest

Diagnostic Automation Inc. URS-2P (100 Strips Bottle) for the semi-quantitative and qualitative detection of Glucose and Protein in Urine.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Urine Reagent Strips, 2-Parameter; Glucose, Protein

Urine reagent strips; 2-parameter; glucose, protein; 100 strips per vial

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Chemstrip 10 MD Test Strips

Catalogue number 3260763160, listed by Roche Diagnostics Gmbh, Germany, under Method, Enzymatic, Glucose (Urinary, Non-Quantitative). 5 manufacturers in China are registered for this product code.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Urine Strips

Catalogue number UrineRS-11-MA, listed by Urit Medical Electronic Co., Ltd., China, under Method, Enzymatic, Glucose (Urinary, Non-Quantitative). 5 manufacturers in China are registered for this product code.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Aimstrip US-3

Dipstick reagent strips for the qualitative detection of Glucose, Protein, & pH in urine.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Chemstrip 9 Urine Test Strips

2 catalogue numbers from 11895427160, listed by Roche Diagnostics Gmbh, Germany, under Method, Enzymatic, Glucose (Urinary, Non-Quantitative). 5 manufacturers in China are registered for this product code.

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Keto-Diastix®

Reagent Strips for Urinalysis: Ketone; Glucose

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Teco Diagnostics

URS-10 100 (Russian) Finished KIT

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