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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device microbial colony image assessment system
Definition A microbial colony image assessment system is an instrument that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, phenotypic and morphologic characteristics. This device type provides a semi-quantitative assessment of colony counts that are used as an aid in the diagnosis of urinary tract infection. All urine culture plates that are identified as positive for growth by the APAS Compact, when using its urine analysis module, must be reviewed by a trained microbiologist.
Product CodePPU
Regulation Number 866.2190
Device Class 2