Gen-Probe

0 510(k) clearances · 2 PMAs

Total clearances

None → None

Last 12 months

Product codes

Most recent

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Portfolio

Code	Device name	Class	Specialty	Clearances	Most recent

Class III

Total PMA records

Originals + supplements

Distinct product codes

First decision

2020-02-14

Most recent

2020-07-21

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2020-07-21	P020011-S016	Aptima HCV RNA Qualitative Assay	30-Day Notice	MZP	Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus	Microbiology
2020-02-14	P020011-S015	Aptima HCV RNA Qualitative Assay	30-Day Notice	MZP	Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus	Microbiology

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Date	K-number	Device	Code	Class	Specialty