Quidel Corp.: FDA filings under this applicant name

FDA lists 128 510(k) clearances under the applicant name “Quidel Corp.” (first 1983, latest 2024), plus 1 PMA and 2 De Novo decisions, across 37 product codes in 5 review panels. Median 510(k) review time under this name: 72 days. Since 2017 the median was 108 days, against 128 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under QuidelOrtho, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Quidel Corp. took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.

Top product codes

Plus 27 more product codes.

Review panels

• Microbiology (75)
• Clinical Chemistry (41)
• Immunology (13)
• Pathology (1)
• Radiology (1)

Most recent Quidel Corp. 510(k) clearances

118 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

15 product recalls in 14 recall events; 6 initiated in the last five years. Most recent: 2026-04-06.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Quidel Corp. is the lead sponsor of 7 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT03238274: Sofia 2 Lyme FIA Whole Blood Clinical Study (Completed, started 2017-06-06)
• NCT03417869: QuickVue Influenza A + B Test Field Study (Completed, started 2017-02-16)
• NCT02566447: "Solana™ Trichomonas Assay Field Study" (Completed, started 2015-10-15)
• NCT01803113: Sofia hCG FIA Field Study (Completed, started 2013-01)
• NCT01734668: Sofia RSV FIA Field Study (Completed, started 2012-03)

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Quidel Corp. (a text match, not an official crosswalk):

• G0008 — Administration of influenza virus vaccine (via GNX)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Quidel Cardiovascular, Inc. (2 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Quidel Corp.?

FDA lists 128 510(k) clearances under the applicant name “Quidel Corp.” (first 1983, latest 2024), plus 1 PMA and 2 De Novo decisions, across 37 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Quidel Corp.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Quidel Corp. is 72 days. Since 2017: 108 days, versus 128 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Quidel Corp.?

The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 20); DHB (System, Test, Radioallergosorbent (Rast) Immunological, 9); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 9).

Next steps

• See all 128 Quidel Corp. clearances with predicates and recalls
• Run predicate analysis for product code JHI, Quidel Corp.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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