FDA product code PFG

Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders

Hematology·Class 2·21 CFR 864.1870
US regulatory classifications
US Product Code (FDA)
PFG
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 864.1870
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Medical specialty
Hematology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.

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About this record

Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders 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.