FDA applicant

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

San Diego, CA3 decisions2026–20260 recalls

FDA records 3 decisions for Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) (San Diego, CA) in 2026: 3 510(k) clearances. Most are in product codes PSZ (Devices Detecting Influenza A, B, And C Virus…) and LSR (Reagent, Borrelia Serological Reagent). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Ortho Clinical Diagnostics Inc. (QuidelOrtho)”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)’s devices, and how often a recall has named them.

FDA decisions per year

3in 2026

2026high 3 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ortho-Clinical Diagnostics, Inc.…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Ortho-Clinical”

FDA records each applicant name separately; these may or may not be the same firm.

Ortho-Clinical Diagnostics, Inc. 152 Ortho Diagnostic Systems, Inc. 126 Ortho Development Corp. 64 Ortho Diagnostics, Inc. 24 Ortho Tec, LLC 22 Ortho Pharmaceutical Corp. 9 Ortho Source 9 Ortho Organizers, Inc. 8 Ortho Kinetics Corp. 7 Ortho Solutions Limited 6 Ortho Instruments 6 Ortho Kinematics, Inc. 6

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Ortho-Clinical”