Becton, Dickinson and Company: PMA supplement approved for BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR HPV Extraction Trough (SKU 44
Becton, Dickinson and Company (Sparks, Maryland): PMA supplement approved for BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR HPV Extraction Trough (SKU 44. Dated 77 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 8 related MD FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Becton, Dickinson and Company |
| Product | BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR HPV Extraction Trough (SKU 444074) |
| Generic / ingredient | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Approval | PMA supplement (device change) |
| Application | P160037 S027 |
| Decided | 2026-08-19 |
| Panel / class | Microbiology |
| Sponsor location | Sparks, MD |
| Peer records CSV (9 MD records) | 🔒 Click to unlock → |
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- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-08-19
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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Peer benchmark and outreach value: Becton, Dickinson and Company and 9 Maryland peers
- Maryland FdaApprovalPulse records like this one: 9
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Maryland peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Becton, Dickinson and Company in Sparks, Maryland?
The FDA approved BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR HPV Extraction Trough (SKU 444074) (P160037 S027) for Becton, Dickinson and Company on 2026-08-19: PMA supplement (device change).
How does Becton, Dickinson and Company compare to other Maryland FdaApprovalPulse records?
It is 77 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
Becton, Dickinson and Company vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Becton, Dickinson and Company | Sparks, MD | 2026-08-19 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Tucson, AZ | 2026-10-23 |
| Cerenovus, Inc. | Miami, FL | 2026-10-23 |
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.