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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, tracrolimus
Regulation Description Tacrolimus test system.
Product CodeMLM
Regulation Number 862.1678
Device Class 2


Premarket Reviews
ManufacturerDecision
SHANGHAI GENEXT MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Microgenics Corporation II Jun-24-2022
2 Siemens Healthcare Diagnostics, Inc. II Mar-15-2023
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