Who else makes this device?

Name: URiSCAN 10 SGL strip
Brand: URiSCAN 10 SGL strip

Clinical Chemistry › Test SystemsMethod, 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)…

Registry build 21.09.26

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) and Leucocytes in urine.

5manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 URiSCAN 10 SGL strip
Listed by	YD Diagnostics, South Korea
FDA product code	JIL
Device type	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device class	Class 2
Regulation	21 CFR 862.1340
Establishment	Manufacturer
510(k)	K952307
Record published	2016-08-05
Record revised	2022-11-28 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for URiSCAN 10 SGL strip
Catalogue number	Size	Status
U391		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
K050801	2005-04-20

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.