QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH
QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH (Delaware): 510(k) cleared for QIAGEN GmbH. Its amount of 90 is below the median of 138 (31st percentile). Dated 41 days ago, it serves as a historical benchmark. Score 36/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 90 · 31th percentile of 414 FDAPulse records · 0.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related DE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262168 |
| Device | QIAstat-Dx BCID GN Plus AMR Panel |
| Applicant | QIAGEN GmbH |
| Specialty / panel | Microbiology |
| Product code | PEN |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-26 |
| Decision date | 2026-09-24 |
| Review time (days) | 90 |
| Third-party review | No |
| Applicant location | Hilden, DE |
| amount percentile | 31th of 414 (median 138, 0.7x median) |
| Peer records CSV (25 DE records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Unlock QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH + all 25 DE records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-24
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (DE first): colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gas · Endox High Level Disinfectant (K254094) · Actolind® (06.3637. Actolind® Gel Plus) (K254168) · UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operat · KARL STORZ SUPRALOOP (K254303) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH's amount: 31st percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Delaware peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 90-day review: this device is a strong predicate for similar products.
- Posted 41 days ago.
What is the FDAPulse record for QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH in Delaware?
QIAstat-Dx BCID GN Plus AMR Panel (K262168) by QIAGEN GmbH was cleared on 2026-09-24 after 90 days of review.
How does QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH compare to other Delaware FDAPulse records?
Its amount of 90 is below the median (31th percentile); smaller records often move faster and face less competition. It is 41 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
QIAstat-Dx BCID GN Plus AMR Panel (K262168) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| QIAstat-Dx BCID GN Plus AMR Panel (K262168) | DE | 2026-09-24 |
| B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302) | DE | 2026-10-23 |
| Elecsys EBV EBNA IgG (K260221) | IN | 2026-10-02 |
| Elecsys EBV VCA IgG (K260232) | IN | 2026-10-02 |
Related records
- B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)
- Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics
- Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics
- Elecsys EBV IgM (K260233): 510(k) cleared for Roche Diagnostics
- VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc.
- DASH Flu A/B Test (K261347): 510(k) cleared for Nuclein, LLC
- Access MeMed BV (K261109): 510(k) cleared for Beckman Coulter, Inc.
- VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc.
- Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid
- Xpert Xpress CoV-2/Flu plus (K263333): 510(k) cleared for Cepheid®
- BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC
- SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc.
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Microbiology devices
More Delaware public-record feeds
Delaware Public Education Organization Directory Pulse in Delaware Largest U.S. Greenhouse Gas Emitters by Company, Sector & State (EPA GHGRP) in Delaware FEMA Hazard Mitigation Project Tracker in Delaware Federal Alcohol Permit Holder Directory in Delaware New NSF Research Awards by Institution in Delaware School & Library E-Rate Contracts Up for Rebid in Delaware New Grants by Vendor Procurement Need in Delaware Carrier Out-of-Service Alerts in Delaware
How to monitor QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH and peer microbiology records
Get new FDAPulse records like QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.