PFT · Class I · 21 CFR 862.3800

FDA Product Code PFT: Reagents For Molecular Diagnostic Test Systems

A Kit That Is A Set Of Reagents And Consumables Used In The Processing Of Human Genomic Dna Samples Derived From Peripheral Whole Blood, And In The Subsequent Targeted Re-sequencing Of The Resulting Sample Libraries. User-supplied Analyte Specific Reagents Are Required For The Preparation Of Libraries Targeting Specific Genomic Regions Of Interest. The Kit Is Intended For Use As Part Of Molecular Diagnostic Test Systems.

1
Total
0
Cleared
46d
Avg days
2013
Since

FDA 510(k) Cleared Reagents For Molecular Diagnostic Test Systems Devices (Product Code PFT)

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About Product Code PFT - Regulatory Context