Ortho-Clinical Diagnostics, Inc. (specification developer, Rochester, NY): 1 new FDA device listing, incl. system, test, automated blood grouping and antibody
Ortho-Clinical Diagnostics, Inc. (Rochester, New York): 1 new FDA device listing, incl. system, test, automated blood grouping and antibody. Its amount of 1 is above the median of 1 (50th percentile). Dated 170 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 55 related NY DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Ortho-Clinical Diagnostics, Inc. |
| Owner / operator | QuidelOrtho Corporation |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198 |
| Location | Rochester, NY, US |
| New listings | 1 |
| Devices | System, Test, Automated Blood Grouping And Antibody |
| Product codes | KSZ |
| Device classes | Class II |
| Medical specialties | Hematology |
| Brand names | Ortho Optix Reader |
| First new listing | 2026-05-18 |
| Latest new listing | 2026-05-18 |
| FDA registration number | 1319681 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x median) |
| Peer records CSV (56 NY records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Ortho-Clinical Diagnostics, Inc.
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 Ortho-Clinical Diagnostics + all 56 NY records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-05-18
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (NY first): Sterigenics U.S., LLC (contract sterilizer, Queensbury, NY) · Endure Industries, Inc. (specification developer, Homer, NY) · Premium Plus Dental Supplies Inc (other, Brooklyn, NY) · Siemens Healthcare Diagnostics Inc. (specification developer · Safetec Of America, Inc. (manufacturer, Buffalo, NY) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 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: Ortho-Clinical Diagnostics, Inc. and 56 New York peers
- New York DeviceEstablishmentPulse records like this one: 56
- Ortho-Clinical Diagnostics, Inc.'s amount: 50th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New York peer: $11,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Ortho-Clinical Diagnostics, Inc. in Rochester, New York?
Ortho-Clinical Diagnostics, Inc. (Rochester, NY), a specification developer (outsources manufacturing), added 1 FDA device listing on 2026-05-18.
How does Ortho-Clinical Diagnostics, Inc. compare to other New York DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 170 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
Ortho-Clinical Diagnostics, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY | 1 | 50th | 2026-05-18 |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI | 3 | 77th | 2026-10-14 |
| Ge Medical Systems, LLC | Waukesha, WI | 3 | 77th | 2026-10-06 |
| Align Technology, Inc. | San Jose, CA | 3 | 77th | 2026-09-30 |
Related records
- Alc Enterprises Inc
- Boston Scientific Corporation
- SHOULDER INNOVATIONS, Inc
- Davol Inc., Sub. C.R. Bard, Inc.
- MEDLINE INDUSTRIES, LP - Northfield
- Ge Medical Systems, LLC
- Align Technology, Inc.
- Orthopediatrics, Corp
- Sol-Millennium Medical, Inc.
- Wright Medical Technology, Inc.
- Arthrex, Inc.
- Deka Research & Development Corp.
DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in New York
More New York public-record feeds
CMS HAC Reduction & Readmissions Penalties by Hospital in New York New & Re-Approved E-Rate Service Providers (FCC Form 498 / SPIN) in New York Carrier Out-of-Service Alerts in New York New York Lead Testing in School Drinking Water Sampling and Results Pulse in New York Newly Funded Companies Likely to Hire in New York New IPO Filings (SEC S-1 & F-1) by Industry & State in New York New York City Medallion Vehicles Pulse in New York New NIH Research Awards by Organization in New York
How to monitor Ortho-Clinical Diagnostics, Inc. and peer specification developer (outsources manufacturing) records
Get new DeviceEstablishmentPulse records like Ortho-Clinical Diagnostics, Inc. 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 new device listings in your specialties
DeviceEstablishmentPulse emails device establishments with new FDA listings matching your roles and states.
✓ 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
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.