# Orient Gene Biotech

- Location (FDA's records): East Stroudsburg, PA
- FDA decisions: 1 (2011–2011): 1 510(k) clearance
- Product codes: KHE (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 1 (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
- Alfa Scientific Designs, Inc.: 1 (https://510kreport.com/company/alfa-scientific-designs)

## Firms that cite its devices most
- Guangzhou Wondfo Biotech Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-wondfo-biotech)

## Its most-cited devices
- K110309: Fob One Step Rapid Test (2011), cited by 1

## Recent decisions
- K110309: Fob One Step Rapid Test (Sep 14, 2011)

Source page: https://510kreport.com/company/orient-gene-biotech