This document specifies the requirements, markings, labels, instructions for use, packaging, transportation, and storage of dry chemical analyzers (hereinafter referred to as analyzers), and describes the corresponding test methods. This document is applicable to analyzers that use solid-phase carrier reagents to perform chemical testing on patient blood, urine, cerebrospinal fluid and other samples in medical clinical settings. This document does not apply to glucose analyzers, urine analyzers, blood gas analyzers, or other dry analyzers.