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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fish based detection of chromosomal abnormalities from patients with hematologic malignancies
Definition Fluorescence In Situ Hybridization (FISH) Test for Hematologic Malignancies is used to detect chromosomal abnormalities in human specimens from patients with hematologic malignancies. The test is indicated for the clinical management of patients consistent with World Health Organization (WHO) guidelines and in conjunction with other clinical and diagnostic criteria. The results are to be interpreted by a pathologist or equivalent professional.
Product CodeQDI
Regulation Number 864.1880
Device Class 2


Premarket Reviews
ManufacturerDecision
CYTOCELL LTD
  GRANTED 1

Recalls
Manufacturer Recall Class Date Posted
1 Cytocell Ltd. II Mar-09-2022
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