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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device culture media, selective and non-differential
Regulation Description Selective culture medium.
Product CodeJSJ
Regulation Number 866.2360
Device Class 1

Device Problems
False Negative Result 2
Incorrect, Inadequate or Imprecise Result or Readings 2
Total Device Problems 4

Recalls
Manufacturer Recall Class Date Posted
1 Acumedia Manufacturers, Inc. III Oct-26-2018
2 Hardy Diagnostics II Apr-26-2016

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