Printed For Final Review: 10/10/03
ECO Number: 27341
European Communities Hazardous Substance Risk Phrases (Council Directive
1999/45/EC)
R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed.
R32 - Contact with acids liberates very toxic gas.
S28 - After contact with skin, wash immediately with plenty of water.
REAGENTS CONTAINING THIMEROSAL
Some reagents in this kit contain thimerosal which contains a mercury compound.
Disposal of elemental mercury, inorganic mercury, mercury oxides, and mercury
compounds should be done in strict compliance with all local, state, and federal
regulations.
WARNING: This product contains a chemical known to the State of California to cause
birth defects or other reproductive harm.
REAGENTS CONTAINING IODINE-125
This kit contains radioactive material which does not exceed 1.5 µCi (55.5 kBq-kit
51065) or 3 µCi (111 kBq-kit 51130) of iodine-125. Appropriate precautions and good
laboratory practices should be used in the storage, handling, and disposal of this
material.
For practitioners or institutions receiving radioisotopes under a general license:
This radioactive material may be received, acquired, possessed, and used only by
physicians, veterinarians in the practice of veterinary medicine, clinical laboratories, or
hospitals, and only for in vitro clinical or laboratory tests not involving internal or
external administration of the material, or the radiation therefrom, to human beings or
animals. Its receipt, acquisition, possession, use, and transfer are subject to the
regulations and the general license of the U.S. Nuclear Regulatory Commission or of
the state with which the Commission has entered into an agreement for the exercise of
regulatory authority.
1. Storage of radioactive material should be limited to a specifically designated area.
2. Access to radioactive materials must be limited to authorized personnel only.
3. Do not pipette radioactive material by mouth.
4. Do not eat or drink within designated radioactive work areas.
5. Areas where spills may occur should be wiped up, then washed with an alkali
detergent or radiological decontamination solution. Any glassware used must be
rinsed completely with water before washing with other laboratory glassware.
For practitioners or institutions receiving radioisotopes under a specific license:
The receipt, use, transfer, and disposal of radioactive materials are subject to the
regulations and conditions of your specific license.
WARNING: This product contains a chemical known to the State of California to cause
cancer.
ATTENTION: Radioactivity printed in the package insert may be slightly different from
the radioactivity printed on the box label and on the tracer vial label. The box label and
the tracer vial label indicate the actual amount of radioactivity at the calibration date
where the package insert indicates the theoretical radioactivity of the kit.
6.
INDICATIONS OF POSSIBLE DETERIORATION OF KIT REAGENTS
6.1 The presence of particulate matter in any of the reagents.
6.2 A shift in the slope or position of the calibrator curve from what is normally
obtained.
6.3 A decrease in maximum binding.
6.4 A high nonspecific binding.
10:45 AM
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