Product code QDI— Medical Genetics
MLL (KMT2A) Breakapart FISH Probe Kit +4 more
- Classification name
- Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies
- Device class
- Class 2
- Regulation
- 21 CFR 864.1880
- Advisory panel
- Medical Genetics
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QDI
FDA has cleared device under product code QDI, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QDI
Recent clearances under product code QDI
Data sourced from openFDA. This site is unofficial and independent of the FDA.