This standard specifies the requirements, test methods, labels, instructions for use, packaging, transportation and storage of calcium determination reagents (boxes). This standard applies to calcium determination reagents (boxes) for quantitative detection of calcium in serum, plasma and other body fluids using the azoarsenic III method, o-cresolphthalein copper complex method, and methylthymol blue method, including manual reagents and in-process reagents. Reagents used in semi-automatic and fully automatic biochemical analyzers. This standard does not apply to dry chemical determination reagents.