Who else makes this device?

Name: BUN Reagent Kit
Brand: BUN Reagent Kit

Clinical Chemistry › Test SystemsUrease And Glutamic Dehydrogenase, Urea Nitrogen

BUN Reagent Kit

Blood Urea Nitrogen Reagent Kit for use with EasyRA Analyzers

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code CDQ
Manufacturer	City	Province	Registered as	Device types
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61

Record

Regulatory record for BUN Reagent Kit
Listed by	Medica Corp., United States
FDA product code	CDQ
Device type	Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device class	Class 2
Regulation	21 CFR 862.1770
Establishment	Repacker / relabeller, Manufacturer
510(k)	K080823
Record published	2019-02-14

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for BUN Reagent Kit
Catalogue number	Size	Status
10202-4		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
JAS Diagnostics	Drew Scientific, Ltd.	12
Urea	Randox Laboratories Limited	12
Synermed®	Infrared Laboratory Systems LLC	8
Pointe Scientific, Inc.	Horiba Instruments Incorporated	6
AU	Beckman Coulter, Inc.	6
UreaBUN	Roche Diagnostics Gmbh	3
Kinetic UV assay for ureaurea nitrogen	Roche Diagnostics Gmbh	3
Pointe Scientific BUN Liquid	Horiba Instruments Incorporated	3
Alinity	Abbott Medical	2
Architect	Abbott Laboratories	2
Architect	Abbott Medical	2
Urea Nitrogen (BUN) Liqui-UV®	Stanbio Laboratory, L.P.	2

Showing 12 of 49. All products under Urease And Glutamic Dehydrogenase, Urea Nitrogen

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K110675	2011-04-21

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.