# Infectio Diagnostic, Inc.

- Location (FDA's records): Baldwin, MD
- FDA decisions: 1 (2002–2002): 1 510(k) clearance
- Product codes: NJR (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biostar, Inc.: 1 (https://510kreport.com/company/biostar)

## Firms that cite its devices most
- Cepheid: 2 (https://510kreport.com/company/cepheid)

## Its most-cited devices
- K022504: Idi-Strep B Assay (2002), cited by 2

## Recent decisions
- K022504: Idi-Strep B Assay (Nov 18, 2002)

Source page: https://510kreport.com/company/infectio-diagnostic