Pure Global

Quality Control For Molecular Immunohematology Tests

Quality Control For Molecular Immunohematology Tests is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Quality Control For Molecular Immunohematology Tests
Hematology Medical Device Type
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Regulatory Classifications

US Regulatory Classifications

PFK

View Product Code Classification

Class 2

21 CFR 864.9650

View CFR Regulation

Hematology

Device Characteristics

No

No

No

Eligible

Definition

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