Who else makes this device?

Name: Diaslide Urine Culturing Device
Brand: Diaslide Urine Culturing Device

Immunology & Microbiology › Microbiology DevicesKit, Screening, Urine

Diaslide Urine Culturing Device

Diaslide Urine Culture Device (UCD) is a semi-quantitative screening culture device for detecting, enumerating and identifying specific bacteria in urine. The device is intended for use in…

Registry build 21.09.26

Diaslide Urine Culture Device (UCD) is a semi-quantitative screening culture device for detecting, enumerating and identifying specific bacteria in urine. The device is intended for use in physician’s office laboratories and clinical laboratories as an aid in the diagnosis of urinary tract infection (UTI).

7manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Jilin (5), Shandong (2).

Chinese manufacturers registered for FDA product code JXA
Manufacturer	City	Province	Registered as	Device types
Changchun Wancheng BIO-Electron Co., Ltd.	Changchun	Jilin	Contract manufacturer	34
Weihai Kangzheng Medical Equipments Technology Co., Ltd.	Weihai	Shandong	Contract manufacturer	26
Weihai Kangzhou Biotechnology Engineering Co., Ltd.	Weihai	Shandong	Manufacturer	24
Changchun Merydi BIO-Tech Co., Ltd.	Changchun	Jilin	Manufacturer	24
Jilin Hongyi BIO-Tech Co., Ltd.	Changchun	Jilin	Manufacturer	24
Changchun LYZ Technology Co., Ltd.	Changchun	Jilin	Manufacturer	16
Jilin Test BIO-Electron Co., Ltd.	Changchun	Jilin	Manufacturer	9

Record

Regulatory record for Diaslide Urine Culturing Device
Listed by	Savyon Diagnostics Ltd., Israel
FDA product code	JXA
Device type	Kit, Screening, Urine
Device class	Class 1
Regulation	21 CFR 866.2660
Establishment	Contract manufacturer, Manufacturer
510(k)	K921045
Record published	2026-05-04

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 15 to 25 °C

Catalogue Numbers

Catalogue numbers for Diaslide Urine Culturing Device
Catalogue number	Size	Per pack	Status
DS-105		10	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Fisherbrand	Fisher Scientific Company L.L.C.	11
Cardinal Health	Cardinal Health 200, LLC	11
Chromid® CPS® Elite agar/Columbia CNA agar + 5% sheep blood	bioMerieux, Inc.	1
Chromid® CPS® Elite Agar (Cpse)	bioMerieux, Inc.	1
Tri-Tech Forensics, Inc.	TRI-Tech Forensics, Inc.	1
Chromid® CPS® Elite Agar (Cpso)	bioMerieux, Inc.	1
Know Rapid STD Test	MobiLab Medical Innovatives Inc.	1
MobiLab Standard Sexual Health Self Rapid Test	MobiLab Medical Innovatives Inc.	1
Accutest Uriscreen Rapid Screen for UTI. Test	Jant Pharmacal Corp.	1
Uriscreen	Savyon Diagnostics Ltd.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K921045	1992-09-28

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.