GADA Control

GADA Control for 5 to 10 times. Then dissolve the contents

on the top by gentle inversion for
(Glutamic Acid Decarboxylase Antibody
Control) approximately 10 times. Avoid formation of
foam. DO NOT SHAKE.
Positive: 2×1 mL  Take the required volume for each assay.
REF CC209
Negative: 2×1 mL  Dispense control material into several small
vials and keep them at 2-8℃ or -20℃ with
sealed cap for the purpose of further tests.
【MATERIAL PROVIDED】
Avoid repeated freeze-thaw.
The controls are provided in lyophilized form.
 DO NOT RETURN control material to the
The concentration range of each control original vial once taken.
indicates the limits for control values that can be  Establish target values and analytical
obtained in reliable assay runs. ranges for the control material based on the
measurement procedures in the lab.
The main components of the control products are
liquid with different concentrations of mouse 【WARNINGS AND PRECAUTIONS】
GADA and Tris buffer. IVD For in vitro diagnostic use only
 For medical professional use only.
【INTENDED USE】  DO NOT use the product after expiration
GADA Control is used as a means of checking date.
the reliability of GADA assay. The performance  The control values are lot-specific.
of GADA Control has not been evaluated for
other assays or instruments. CAUTION:
All human sourced materials should be
【STORAGE AND STABILITY】 considered potentially infectious. It has been
This product must be stored in unopened vial tested and found that all materials of this product
upright at 2-8℃. GADA Control is stable up to the are nonreactive for HBsAg, anti-HCV, anti-HIV-1,
expiration date as indicated on the label. anti-HIV-2 and anti-TP. There is no testing
Once opened, it is stable within 30 days stored at method that can rule out the potential risk of
2-8°C and within 30 days stored at≤ -20℃. infection with absolute certainty, so this product
should be considered as potential biohazard.1
【REAGENT PREPARATION】
 Gently tap the vial to ensure the control 【ANALYTE】
material is at the bottom of the vial. No. Analyte Name
 Remove the screw cap. 1 GADA
 Carefully lift the rubber stopper to allow air
into the vial, then totally remove it.
 Add exactly 1mL sterile deionized water. 【REFERENCE】
 Put the stopper and cap on and let it stand 1. HHS Publication, 5th edition, December 2009.
for 10 to 20 minutes to dissolve the contents Biosafety in Microbiological and Biomedical
completely, during which gently swirl the vial Laboratories.
1 V1.0 English Ed.2019-09-02
GADA Control
ANNEX B:
WARNINGS AND PRECAUTIONS (Proclin 300)
SHENZHEN YHLO BIOTECH CO., LTD.
 Hazardous Component: 0.05% Proclin 300
Building 1, YHLO Biopark, Baolong 2nd Road,
(Reaction mass of: 5-chloro-2-methyl-4-isothiazolin-
Baolong Subdistrict, Longgang District, 518116
3-one [EC no. 247-500-7] and 2-methyl-4-isothiazolin
Shenzhen, PEOPLE’S REPUBLIC OF CHINA
-3-one [EC no. 220-239-6] (3:1))
 Hazard Statement:
Wellkang Ltd (www.CE-marking.eu)
16 Castle St., Dover, Kent, CT16 1PW, England, H317: May cause an allergic skin reaction.
UK H410: Very toxic to aquatic life with long-lasting
effects.
ANNEX A:  Precautionary Statement:
P261: Avoid breathing dust/ fume/ gas/ mist/ vapours/
Explanation of abbreviation spray.
P272: Contaminated work clothing should not be
Abbreviation Explanation
allowed out of the workplace.
P273: Avoid release to the environment.
REF Catalogue number
P280: Wear protective gloves/protective clothing/eye
protection/face protection.
Manufacturer P302+P352: IF ON SKIN: Wash with plenty of soap
and water.
CE Conformity Marking P333+P313: If skin irritation or rash occurs: Get
medical advice/attention.
Caution P321: Seek immediate care from a doctor.
P363: Wash contaminated clothing before reuse.
LOT Batch code P391: Collect spillage.
P501: Dispose of contents/container in a safe way.
Use-by date

Biological risks

Pictograms for Caution

Pictograms for Hazardous to

the aquatic environment
Temperature limit
(2-8°C)

This way up

Authorized representative in
the European community
In vitro diagnostic medical
device

Consult instructions for use

2 V1.0 English Ed.2019-09-02