Who else makes this device?

Name: Combistix® Reagent Strips
Brand: Combistix® Reagent Strips

Clinical Chemistry › Test SystemsMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)

Combistix® Reagent Strips

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

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

3recalls on this 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 Combistix® Reagent Strips
Listed by	Siemens Healthcare Diagnostics Inc, United States
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, Complaint-file establishment, Manufacturer, Exporter
510(k)	K992257
Record published	2016-09-24
Record revised	2022-11-28 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date
Storage	Special storage condition: Do not store in direct sunlight.; Storage environment temperature 15 to 30 °C

Catalogue Numbers

Catalogue numbers for Combistix® Reagent Strips
Catalogue number	Size	Per pack	Status
10337932		100	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
K091216	2009-10-09

Recalls

3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2014-09-19	Class II	Process control	The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.	approx. 4200	2015-07-20
2014-09-19	Class II	Process control	The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.	approx. 4200	2015-07-20
2014-09-19	Class II	Process control	The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.	approx. 4200	2015-07-20

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.