Digene Hybrid Capture 2 (HC2) Hpv Dan Test
PMA P890064
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP890064 | Date11 Mar 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Viratype Human Papillomavirus DNA Typing Kit
- Generic Name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- PMA Number
- FDA Product Code
- MAQ
- Device Class
- Class III
- Advisory Committee
- Microbiology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The DIGENE Hybrid Capture 2 HPV DNA Test is an in vitro diagnostic device classified as a Kit, DNA Detection, Human Papillomavirus, designed for the qualitative detection of high-risk human papillomavirus (HPV) types in cervical specimens. It employs molecular hybridization technology to identify oncogenic HPV DNA, aiding in the screening and triage of cervical abnormalities.
This test is supplied as a single-use reagent kit and requires laboratory processing. It is intended for use in clinical microbiology laboratories and has been authorized under an FDA Premarket Approval (PMA) with PMA number P890064. The device operates under sterile conditions and is regulated under the MAQ product code, adhering to strict quality and safety standards for in vitro diagnostics.
Questions
AI-generated answers, 18 Sep 2026
What is the DIGENE Hybrid Capture 2 HPV DNA Test used for in clinical practice?
The DIGENE Hybrid Capture 2 HPV DNA Test is designed for the **qualitative detection of high-risk human papillomavirus (HPV) types** in cervical specimens. It uses molecular hybridization technology to identify oncogenic HPV DNA, helping clinicians screen for and triage cervical abnormalities, particularly in cervical cancer risk assessment.
Is the DIGENE Hybrid Capture 2 HPV DNA Test intended for single-use or repeated use?
The test is supplied as a **single-use reagent kit**, meaning each kit is intended for one test procedure. This ensures sterility and prevents cross-contamination, as it requires laboratory processing and cannot be reused.
How is the regulatory status of this device determined, and what does that mean for its use?
The device holds an **FDA Premarket Approval (PMA) under PMA number P890064**, meaning it has undergone rigorous review by the FDA to ensure safety and effectiveness. This approval allows its use in clinical microbiology laboratories for the specified purpose of detecting high-risk HPV types in cervical specimens, adhering to strict regulatory standards.
What type of laboratory setting is required to use the DIGENE Hybrid Capture 2 HPV DNA Test?
The test is **intended exclusively for use in clinical microbiology laboratories**, as it requires specialized equipment and trained personnel to process the reagent kit. It is not designed for point-of-care or home-use settings.
Are there different versions or sizes of the DIGENE Hybrid Capture 2 HPV DNA Test available?
The provided data does not specify multiple sizes or models of the DIGENE Hybrid Capture 2 HPV DNA Test. It is supplied as a **single standardized reagent kit** for qualitative HPV detection, with no variations mentioned in the regulatory records.