VIRAPAP Human Papillomavirus DNA Detection Kit
FDA PMAClass III (US FDA PMA)
by Qiagen, Inc.
Identity
- Trade Name
- VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT FDA PMA
- Generic Name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS FDA PMA
Identifiers
- PMA Number
- P880009 FDA PMA
- FDA Product Code
- MAQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APWD FDA PMA
The VIRAPAP Human Papillomavirus DNA Detection Kit is a diagnostic device designed for the detection of human papillomavirus (HPV) DNA in clinical specimens. It is classified as a Kit, DNA Detection, Human Papillomavirus under FDA device classification.
This kit is supplied for use in laboratory settings and has received FDA Premarket Approval (PMA) under number P880009. It is intended for in vitro diagnostic use and is not described as sterile, single-use, or reusable in the provided data.
Frequently asked questions
What is the VIRAPAP Human Papillomavirus DNA Detection Kit used for?
The VIRAPAP Human Papillomavirus DNA Detection Kit is used for the detection of human papillomavirus (HPV) DNA in clinical specimens, as indicated by its generic name and device classification as a Kit, DNA Detection, Human Papillomavirus.
Who manufactures the VIRAPAP HPV DNA Detection Kit?
The VIRAPAP Human Papillomavirus DNA Detection Kit is manufactured by Qiagen, Inc., as stated in the manufacturer and applicant fields of the device data.
What regulatory authorization does the VIRAPAP kit have?
The VIRAPAP Human Papillomavirus DNA Detection Kit has FDA Premarket Approval (PMA) authorization, with PMA number P880009 and decision date of December 23, 1988, as shown in the AUTHORIZATIONS and PMA_NUMBER fields.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P880009 | Class III | Active |
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Manufacturer
- Manufacturer
- Qiagen, Inc.
Sources (1)
- FDA PMA P880009 24 fields · synced Sep 18, 2026