Countess® Automated Cell Counter IQ/OQ User-Performed Test Procedures
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In regulated laboratories (typically GxP and ISO), compliance with government and international standards requires documented verification that systems are installed and functioning according to their operational specifications. This IQ⁄OQ (Installation Qualification⁄Operational Qualification) User-Performed Test Procedures package provides you with test procedures to qualify that your Countess® Automated Cell Counter is installed and operating to manufacturer’s specifications. Procedures should be performed during installation or before a previously-installed system will be used in a regulated test environment.
Package includes a bound, printed copy of test procedures. Directions for performing the test procedures can be found in the instrument user manual.
Note that the consumables listed below will need to be on hand or purchased along with the Countess® IQ⁄OQ user-performed test procedures.
• C10284 Countess® test beads for use with the Countess® automated cell counter, 1x10^6 beads⁄mL ±10%
• C10286 Countess® USB drive for use with the Countess® automated cell counter
• T10282 Trypan blue stain 0.4% for use with the Countess® automated cell counter, 2 × 1 ml
* Life Technologies makes no representation whatsoever that the IQ⁄OQ test procedures satisfy or will satisfy any requirements of any governmental body or other organization, including, but not limited to, any requirement of the United States Food and Drug Administration or the International Organization for Standardization. The instrument owner agrees that it is the instrument owner’s responsibility to ensure that the IQ⁄OQ test procedures are adequate to meet its regulation⁄certification requirements. All requirements of any governmental body or other organization, including, but not limited to, any requirement of the United States Food and Drug Administration or the International Organization for Standardization are the responsibility of the software licensee.
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