Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

QDI · Class II — Moderate Risk (510(k) clearance required) · Medical Genetics · 21 CFR 864.1880

Classification

FDA Product Code: QDI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.1880
Review panel: PA
Medical specialty: Medical Genetics
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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 data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown