IAA Control

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

on the top by gentle inversion for
(Insulin Autoantibody Control)
approximately 10 times. Avoid formation of
Positive: 2×1 mL foam. DO NOT SHAKE.
REF CC210  Take the required volume for each assay.
Negative: 2×1 mL
 Dispense control material into several small
vials and keep them at 2-8℃ or -20℃ with
【MATERIAL PROVIDED】
sealed cap for the purpose of further tests.
The controls are provided in lyophilized form.
Avoid repeated freeze-thaw.
 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
lyophilized products with different concentrations
【WARNINGS AND PRECAUTIONS】
of mouse IAA and PBS buffer matrix.
IVD For in vitro diagnostic use only
 For medical professional use only.
【INTENDED USE】
 DO NOT use the product after expiration
IAA Control is used as a means of checking the
date.
reliability of IAA assay. The performance of IAA
 The control values are lot-specific.
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℃ . IAA 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 1 day stored at
method that can rule out the potential risk of
20-25℃，within 2 days stored at 2-8°C and within
infection with absolute certainty, so this product
30 days stored at≤ -20℃.
should be considered as potential biohazard.1

【REAGENT PREPARATION】
【ANALYTE】
 Gently tap the vial to ensure the control
material is at the bottom of the vial. No. Analyte Name

 Remove the screw cap. 1 IAA

 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
IAA 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)
H317: May cause an allergic skin reaction.
16 Castle St., Dover, Kent, CT16 1PW, England,
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