Who else makes this device?

Name: Chemstrip 2 GP Urine Test Strips
Brand: Chemstrip 2 GP Urine Test Strips

Clinical Chemistry › Test SystemsMethod, 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.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (2), Jilin (1), Guangxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JIL
Manufacturer	City	Province	Registered as	Device types
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Urit Medical Electronic Co., Ltd.	Guilin	Guangxi	Contract manufacturer	28
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Chong Qing Teco Huayi Pharm. Co.	Shapingba Dist.	Chongqing	Contract manufacturer	18

Record

Regulatory record for Chemstrip 2 GP Urine Test Strips
Listed by	Roche Diagnostics Gmbh, Germany
FDA product code	JIL
Device type	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device class	Class 2
Regulation	21 CFR 862.1340
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K896454
Record published	2016-09-20
Record revised	2022-11-28 (version 5)

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 30 °C

Catalogue Numbers

Catalogue numbers for Chemstrip 2 GP Urine Test Strips
Catalogue number	Size	Status
11895362160		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Teco Diagnostics	Teco Diagnostics	19
Mission Urinalysis Reagent Strips	Acon Laboratories, Inc.	11
McKesson	Mckesson Medical-Surgical Inc.	5
Henry Schein	Henry Schein, Inc.	5
Keto-Diastix®	Ascensia Diabetes Care US Inc.	2
Chemstrip 9 Urine Test Strips	Roche Diagnostics Gmbh	2
Medline	Medline Industries, Inc.	2
Aution MAX™ AX-4060 Analyzer	Arkray USA, Inc.	2
Diastix®	Ascensia Diabetes Care US Inc.	2
Aimstrip US-3	Germaine Laboratories, Inc.	1
Urine Strips	Urit Medical Electronic Co., Ltd.	1
Chemstrip 10 MD Test Strips	Roche Diagnostics Gmbh	1

Showing 12 of 34. All products under Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K183432	2019-05-07
K032437	2003-10-08
K012397	2001-09-26

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.