Quality Control For Molecular Immunohematology Tests

PFK · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.9650

Classification

FDA Product Code: PFK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.9650
Review panel: PA
Medical specialty: Hematology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 3

Source

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