FDA product code PFF

High Throughput Dna Sequence Analyzer

Immunology·Class 2·21 CFR 862.2265
US regulatory classifications
US Product Code (FDA)
PFF
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.2265
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Medical specialty
Immunology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample.

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About this record

High Throughput Dna Sequence Analyzer is a medical device type in the Immunology 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.