# Asuragen, Inc.

- Location (FDA's records): Austin, TX
- FDA decisions: 3 (2012–2020): 1 510(k) clearance and 2 De Novo grants
- Product codes: OYX (1), OZF (1), OYV (1)
- Predicates its devices cite: 2 (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
- Preanalytix GmbH: 2 (https://510kreport.com/company/preanalytix)

## Firms that cite its devices most
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)
- Cepheid: 1 (https://510kreport.com/company/cepheid)

## Its most-cited devices
- DEN160003: Quantidex qPCR BCR-ABL IS Kit (2016), cited by 2

## Recent decisions
- DEN190023: AmplideX Fragile X Dx & Carrier Screen Kit (Feb 21, 2020)
- DEN160003: Quantidex qPCR BCR-ABL IS Kit (Jul 22, 2016)
- K113420: Rnaretain (Mar 16, 2012)

Source page: https://510kreport.com/company/asuragen