FDA applicant

Infectio Diagnostic (I.D.I.), Inc.

Hydes, MD2 decisions2004–20044 recalls

FDA records 2 decisions for Infectio Diagnostic (I.D.I.), Inc. (Hydes, MD) in 2004: 2 510(k) clearances. All are in product code NQX (System, Nucleic Acid Amplification Test, Dna…). Its devices cite 2 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices.

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 Infectio Diagnostic (I.D.I.), Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Infectio Diagnostic (I.D.I.), Inc. since 2007.

Recalls per year

3in 2008

2007high 3 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Infectio Diagnostic (I.D.I.), Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Infectio Diagnostic (I.D.I.), 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 “Infectio”

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

Infectio Diagnostic, Inc. 1

Infectio Diagnostic (I.D.I.), Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Infectio”