Who else makes this device?

Clinical Chemistry › Test SystemsUrinalysis Controls (Assayed And Unassayed)

Assayed Urine Control – Level 2 (URN ASY Control 2)

Catalogue number AU2352, listed by Randox Laboratories Limited, United Kingdom, under Urinalysis Controls (Assayed And Unassayed). 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Jilin (1), Zhejiang (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code JJW
Manufacturer	City	Province	Registered as	Device types
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Urit Medical Electronic Co., Ltd.	Guilin	Guangxi	Contract manufacturer	28

Record

Regulatory record for Assayed Urine Control – Level 2 (URN ASY Control 2)
Listed by	Randox Laboratories Limited, United Kingdom
FDA product code	JJW
Device type	Urinalysis Controls (Assayed And Unassayed)
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
510(k)	K043266
Record published	2019-06-04

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Assayed Urine Control – Level 2 (URN ASY Control 2)
Catalogue number	Size	Status
AU2352		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Kova	Kova International Inc	52
Urine Control	Chromsystems Instruments & Chemicals Gmbh	16
Urinalysis Controls (Assayed And Unassayed)	Alta Diagnostics, Inc.	14
Cardinal Health	Cardinal Health 200, LLC	10
qUAntify	Bio-Rad Laboratories Inc.	10
McKesson	Mckesson Medical-Surgical Inc.	7
DxU	Beckman Coulter, Inc.	6
Cardinal Health	Kova International Inc	6
MAS UA Control Liquid Assayed Urinalysis Control	Microgenics Corporation	5
Quality Control Solution For Urine Analyzer	Urit Medical Electronic Co., Ltd.	4
Urine Control Bi-Level	Chromsystems Instruments & Chemicals Gmbh	4
Mission Liquid Urine Controls	Acon Laboratories, Inc.	4

Showing 12 of 77. All products under Urinalysis Controls (Assayed And Unassayed)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K110846	2011-09-30
K043266	2005-02-15

Recalls

1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. 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
2019-07-25	Class III	Under Investigation by firm	Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.	1 kit	2020-12-03

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.