IASOcholine Hardware Kit

Iasocholinehardwarekit Cp Cholinekit E 032016 V1 4

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Single Use Hardware Cassettes for IASOcholine® Synthesis with GE TRACERlab MX FDG

The IASOcholine® hardware cassette is a sterile single use plastic cassette, specially designed to produce IASOcholine® ([¹⁸F] Fluoro-Choline) with GE TRACERlab MXFDG according to the IASON dossier for IASOcholine®.

IASOcholine® hardware cassette was developed under strict quality assurance aspects and due to long year experiences in PET tracer development and synthesis.

The IASOcholine® hardware cassettes are produced for IASON by Rotem Industries Ltd, assembled in Class C Clean Rooms. All materials and activities meet the current GMP requirements. The manufacturer is EU GMP, ISO 9001/13485 and 17025 certified as well as a FDA inspected facility.

The cassettes are exposed to 2.5 Mrad (25 kGy) minimum gamma irradiation.

To be able to perform an IASOcholine® synthesis, an upgrade of the GE TRACERlab MXFDG has to be done.

Supplied with full documentation of conformance to specification.

Outer dimensions (package): appr. 56 x 10 x 2,5 cm Available package size: 60 pcs.

Storage at room temperature

Therapeutic indications. This medicinal product is for diagnostic use only.

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