Who else makes this device?

Name: Urine Chemistry Standard Kit
Brand: Urine Chemistry Standard Kit

Clinical Chemistry › Test SystemsCalibrator, Multi-Analyte Mixture

Urine Chemistry Standard Kit

The Urine Chemistry Standard Kit is an in vitro diagnostic calibrator used to calibrate or verify the calibration of clinical chemistry test systems. It provides aqueous primary-standard…

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The Urine Chemistry Standard Kit is an in vitro diagnostic calibrator used to calibrate or verify the calibration of clinical chemistry test systems. It provides aqueous primary-standard solutions containing known amounts of the components being measured. It is a laboratory reference material for analytical testing.

Concentrations are assigned by weighing known-purity source materials to establish a weight-per-volume value. The assigned concentrations are checked using available NIST Standard Reference Materials or equivalent primary standards. Reference methods are also used when available.

Lot Information

A certificate of analysis accompanies each kit and identifies the method used to verify the gravimetric concentrations. The materials are lot certified. Their role is to support calibration and calibration verification of the clinical chemistry system.

3manufacturers in China registered for this device type

1catalogue number

6510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jilin (1), Guangdong (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code JIX
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19

Record

Regulatory record for Urine Chemistry Standard Kit
Listed by	Verichem Laboratories, Inc., United States
FDA product code	JIX
Device type	Calibrator, Multi-Analyte Mixture
Device class	Class 2
Regulation	21 CFR 862.1150
Establishment	Contract manufacturer, Manufacturer
510(k)	K112834
Record published	2018-01-16
Record revised	2018-07-06 (version 3)

Specifications

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

Catalogue Numbers

Catalogue numbers for Urine Chemistry Standard Kit
Catalogue number	Size	Status
9000		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Stat Profile	Nova Biomedical Corporation	54
BioPlex 2200	Bio-Rad Laboratories Inc.	32
Plasma Calibrator Set	Chromsystems Instruments & Chemicals Gmbh	22
Phoenix Diagnostics	Phoenix Diagnostics, Inc.	20
Nova	Nova Biomedical Corporation	15
Plasma Calibration Standard	Chromsystems Instruments & Chemicals Gmbh	15
Phoenix Diagnostics, Inc.	Phoenix Diagnostics, Inc.	15
Architect	Abbott Laboratories	11
Alinity	Abbott Medical	10
Synchron	Beckman Coulter, Inc.	9
Architect	Abbott Medical	9
Urine Calibration Standard	Chromsystems Instruments & Chemicals Gmbh	8

Showing 12 of 229. All products under Calibrator, Multi-Analyte Mixture

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K112834	2012-03-28
K974290	1997-12-19
K973345	1997-10-29
K972333	1997-07-23
K875285	1988-09-02
K882116	1988-06-24

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.