IDS IGFBP-3 Control Mode D'emploi

IDS IGFBP-3 Control
Product Name
Abbreviated Product Name
Systems
1. Intended Use
For In Vitro Diagnostic Use.
The IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set is for in vitro diagnostic use, for the quality
control of the IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) assay on the IDS systems.
2. Summary and Explanation
The regular use of control samples at several analyte levels is advised to ensure day-to-day validity of results. The IDS-iSYS
Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set contains buffered protein at three concentrations of
IGFBP-3. The controls are used for monitoring the accuracy and precision of the IDS IGFBP-3 assay.
3. Warnings and Precautions
The IDS IGFBP-3 Control Set is for in vitro diagnostic use only and is not for internal use in humans or animals. This product
must be used strictly in accordance with the instructions set out in the Instructions for Use. Immunodiagnostic Systems Limited
(IDS) will not be held responsible for any loss or damage (except as required by statute) howsoever caused, arising out of non-
compliance with the instructions provided.
Rx Only
CAUTION: This kit contains material of animal origin. Handle kit reagents as if capable of transmitting an infectious agent.
Appropriate precautions and good laboratory practice must be used in the storage, handling and disposal of the kit reagents.
Disposal of kit reagents should be in accordance with local regulations.
Human materials
Human material used in the preparation of this product has been tested by FDA recommended assays for the presence of
antibody to Human Immunodeficiency Virus (HIV I and II), Hepatitis B surface antigen, antibody to Hepatitis C, and found negative.
As no test can offer complete assurance that infectious agents are absent, the reagents should be handled according to Biosafety
Level 2.
Sodium Azide
Controls contain sodium azide 1.2% (w/w). Sodium azide may react with lead, copper or brass plumbing to form highly explosive
metal azides. On disposal, flush with large volumes of water to prevent azide build up.
Classification under CLP:
Acute Tox. 4
Aquatic Chronic 3
Hazard statements:
EUH032 Contact with acids liberates very toxic gas
H302 Harmful if swallowed
H412 Harmful to aquatic life with long lasting effects
4. Handling Precautions
The IDS IGFBP-3 controls are lyophilised. Store the controls in an upright position at 2 to 8°C prior to use.
Storage
Before opening at 2 to 8°C
After reconstitution in aliquot at -20°C
On board the system*
* Continuous on board stability
IS-4430 V07
IDS-iSYS Insulin-like Growth Factor Binding Protein 3
(IGFBP-3) Control Set
IDS IGFBP-3 Control
IDS-iSYS Multi-Discipline Automated System
IDS-i10
Precautionary statements:
P264
P270
P273
P301/310 IF SWALLOWED: Immediately call a POISON
P330
12 April 2019
Wash hands thoroughly after handling.
Do not eat, drink or smoke when using this product.
Avoid release to the environment.
CENTER or doctor.
Rinse mouth.
Duration
To the expiry date
28 days
3 hours
English
IS-4430
IS-310400
IS-810400
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