UQ-11 Urinalysis Control

PLEASE CAREFULLY READ THIS PACKAGE INSERT BEFORE USE.

For In Vitro Diagnostic Use Only.

INTENDED USEUQ-11 Urinalysis Control is intended for use as assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in this instruction for use . For professional use only.SUMMARYUQ-11 Urinalysis Control is a ready-to-use liquid formulation that works with most popular urine strips and can be used with automated strip readers. UQ-11 Urinalysis Control NO.I is Negative control, NO.IIis Positive control (except Ascorbic Acid), NO.III is Positive control for Ascorbic Acid only.REAGENTUQ-11 urinalysis control is prepared in an aqueous base by adding chemicals, constituents of animal origin, preservatives and stabilizers. This production does not contain the substances distilled from urine.PROCEDUREThis product should be treated the same as patient specimen and run in accordance with the instructions accompanying the instrument, kit, or reagent being used.1. Before sampling, allow the control to reach 18 to 30�.2. Remove the screw cap, draw the control sample across all the reagent areas, thoroughly saturating each pad. Or you can also pour out the control into cuvette and dip the urine reagent strip into the liquid. When use with cuvette, one bottle of control could supply tests no more than 6 times. Don’t mix the used control with the unused quality control together.LIMITATIONS1. This product is not intended for use as a standard .2. If there is evidence of microbial contamination or excessive turbidity in the product discard the vial. CAUTIONS1. This product is for professional use only.2. While the use of urinalysis control is finished each time, please screw down the cover as soon as possible and store it according to Storage and Stability section.3. If the urinalysis control is opened too long or the environmental temperature is not at 18 to 30�, the testing result maybe low or high.4. Since there is no way to ensure that is out of the risk of infection, then the quality control needs to be handled carefully as the solution to clinical samples. After use, dispose as the medical waste. If the liquid touches the eyes and skin, clean it immediately.STORAGE AND STABILITYThis product will be stable until the expiration date when stored unopened at 2 to 8 and out of light. �

Once the control is opened and stored tightly capped, all analytes will be stable for 15 days at 2 to 8�, or 5 days at 18 to 25�. This product should never be frozen.AVAILABILITYNO.I : 8mL�1, NO.II : 8mL�1, NO.III : 8mL�1.ASSIGNMENT OF VALUESThe results printed in the accessory sheet are specific for this lot of product. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacture test method modifications. Each laboratory should use the results provided only as a reference and establish its own parameters of precision.

Urine Analyzers URIT Bayer ARKRAY Roche

Reagent Strips URIT/Uritest 10 /11 series Multistix 10SG Aution Sticks 10EA Combur Test

pH 4.5~6.0 5.0~6.0 5.0~6.0 5.0~6.5

Nitrite - Negative neg. neg.

Glucose - Negative norm. norm.

Specific Gravity 1.000~1.015 �1.005~1.015 1.000~1.010 1.005~1.015

Blood - Negative neg. neg.

Protein - Negative neg. neg.

Bilirubin - Negative neg. neg.

Urobilinogen Normal 3.2µmol/L norm. norm.

Ketone - Negative neg. neg.

Leukocytes(WBC) - Negative neg. neg.

NO. I

Ascorbic Acid -

pH 6.5~7.5 6.5~7.5 6.5~8.0 6.5~8.0

Nitrite + Postive +1~+2 pos.

Glucose +1~+4 +1~+3 +2~+4 +3~+4

Specific Gravity 1.005~1.02 5 1.015~1.025 1.000~1.015 1.005~1.020

Blood +1~+3 +1~+3 +1~+3 +2~+5

Protein +2~+3 +2~+3 +2~+4 +2~+4

Bilirubin +2~+3 +2~+3 +2~+4 +1~+3

Urobilinogen +1~+3 16~131µmol/L +1~+4 +2~+4

Ketone �~+3 �~+2 +3~+4 +2~+4

NO.II

Leukocytes(WBC) �~+3 �~+2 75~500�Leu/µl � +1~+3

NO.III Ascorbic Acid +1~+3

EXPLANATIONS FOR SYMBOLS ON THE LABEL

Guilin Medical Electronic Instrument FactoryNo.4 East Alley, Jiuhua Road, Guilin, Guangxi 541001, PR ChinaTel: +86(773)2693959 Fax: +86(773)2693847Email: service@uritest.comSupplied by:URIT Medical Electronic Co., Ltd

http://www.urit.com Rev.02/2009

Wellkang Ltd t/a Wellkang Tech Consulting Suite B, 29 Harley Street, LONDON W1G 9QR, UK

In vitro diagnostic medical device Lot number Use by

Temperature limitation Keep away from sunlight Consult instructions for use

Manufacturer Authorized Representative in the European Community

This product fulfils the requirements of Directive 98/79/EC on in vitro diagnostic medical devices.