510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QDIClass II

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

21 CFR 864.1880 / Medical Genetics
FDA source (opens on fda.gov)

QDI is the FDA product code for Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies, a class II device type, regulated under 21 CFR 864.1880. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
QDI
Device name
Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies
FDA 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.
Regulation
21 CFR 864.1880
Device class
Class II
Review panel
Medical Genetics
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
1

Clearances, product code QDI

By decision year
1 clearance under product code QDI with a decision year between 2018 and 2018, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QDI by decision year
YearClearances
20181

Applicants with the most clearances

Product code QDI
Applicants holding the most 510(k) clearances under product code QDI
ApplicantClearances
Cytocell Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code