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FDA PRODUCT CODE · CLASS II

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

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

DEVICE CLASS
Class II
REGULATION
21 CFR 864.1870
MEDICAL SPECIALTY
Hematology
REVIEW PANEL
PA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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