Kit, Dna Detection, Human Papillomavirus
The human papillomavirus (HPV) DNA detection kit is an in vitro diagnostic device designed to identify the presence of HPV genetic material in patient samples, supporting screening and diagnosis of HPV-related conditions including cervical cancer risk assessment. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence demonstrating safety and effectiveness. The product code is MAQ and no regulation number or medical specialty has been formally assigned. The device is not an implant and does not sustain life.
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Basic Information
- Product Code
- MAQ
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- MI
- Submission Type
- 2
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.