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- Overview
- Specifications
- eIFUs and Resources
- FAQ
- Product Notifications
The BD Onclarity™ HPV Assay is FDA and Health Canada approved for extended genotyping, offering the flexibility you need to adapt to changing screening guidelines and evolving patient management guidance.
FDA and Health Canada approved for all three screening paradigms:
In the post-vaccination era the prevalence of high-risk genotypes may change making it crucial to identify high-risk genotypes individually.
- Extended genotyping supports risk stratification and persistence monitoring to guide patient management1-5
- Genotypes 16 and 18 account for 70% of invasive cancer worldwide, but their prevalence is declining as vaccination rates increase.6-9
- Genotypes 31,33,58 have a CIN3+ risk similar to genotype 18, but 51,35,39,68,56,59,66 have a much lower risk.10-11
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FEATURE AND BENEFIT CARDS NOT AVAILABLE
FEATURE AND BENEFIT CARDS NOT AVAILABLE
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GTIN - each
00382904429676
1
Quantity - Each
1
Shelf Life (Days)
0
GTIN
| GTIN - each | 00382904429676 | 1 |
Packaging
| Quantity - Each | 1 |
Storage and Handling
| Shelf Life (Days) | 0 |
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Things to Consider
If you are a patient or end user, you can contact us yourself, or you may have your caregiver or your physician do that for you. To help us process your
information quickly and effectively, please contact our customer complaints
team.
To better facilitate our investigation, please include the following information in your reporting:
- Product Name and/or Catalog Number
- Lot Number or Serial Number
- Any injuries and/or Harm?
- What is the issue you experienced?
- Is the actual sample or sample representative available? (If possible, please send affected sample)
- Contact name and phone number
Recall Notifications
These recall notices provide current information on medical device recalls.
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