A - Human Necessities – 61 – L
Patent
A - Human Necessities
61
L
A61L 2/08 (2006.01) A61B 5/15 (2006.01) A61B 17/32 (2006.01) A61L 2/00 (2006.01) C12Q 1/00 (2006.01) G01N 33/48 (2006.01) A61B 5/00 (2006.01)
Patent
CA 2453741
A method for manufacturing a sterilized and calibrated biosensor-based medical device (e.g., an integrated biosensor and lancet medical device) includes sterilizing a biosensor-based medical device that contains a biosensor reagent composition (e.g., an analyte specific enzyme and mediator biosensor reagent composition). The sterilizing can be accomplished using, for example, a gamma radiation based technique. Thereafter, the biosensor reagent composition of the sterilized biosensor- based medical device is calibrated. Another method for manufacturing a sterilized and calibrated biosensor-based medical device includes first assembling and packaging a plurality of biosensor-based medical devices that include a biosensor reagent composition. The packaged biosensor-based medical devices are then sterilized using a radiation- based sterilization technique, to create a plurality of sterilized, packaged biosensor-based medical devices. Thereafter, the sterilized and packaged biosensor-based medical devices are calibrated. The calibration can be accomplished, for example, using a statistical sample of the plurality of sterilized, packaged biosensor-based medical devices.
Lifescan Inc.
Ogilvy Renault Llp/s.e.n.c.r.l.,s.r.l.
LandOfFree
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