QDI · Class II · 21 CFR 864.1880

FDA Product Code QDI: Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

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.

1
Total
0
Cleared
448d
Avg days
2018
Since

FDA 510(k) Cleared Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies Devices (Product Code QDI)

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About Product Code QDI - Regulatory Context