# OraSure Technologies, Inc.

- Location (FDA's records): Bethlehem, PA
- FDA decisions: 31 (1996–2019): 29 510(k) clearances, 1 De Novo grant and 1 original PMA approval
- Product codes: GEH (6), DIO (4), MKU (3), JXM (2), LDJ (2), LCM (2), DIS (2), DKZ (2), DJG (2), DJR (1), LAF (1), CFR (1)
- Predicates its devices cite: 12 (3 its own); citations of its devices by later devices: 42 (3 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Solarcare Technologies Corp,Inc.: 3 (https://510kreport.com/company/solarcare-technologies)
- Roche Diagnostic Systems, Inc.: 3 (https://510kreport.com/company/roche-diagnostic-systems)
- Wartner Medical Products: 2 (https://510kreport.com/company/wartner-medical-products)
- Epitope, Inc.: 1 (https://510kreport.com/company/epitope)

## Firms that cite its devices most
- Microgenics Corp.: 6 (https://510kreport.com/company/microgenics)
- Lin-Zhi International, Inc.: 5 (https://510kreport.com/company/lin-zhi-international)
- Branan Medical Corp.: 5 (https://510kreport.com/company/branan-medical)
- 3jt Enterprises, LLC: 4 (https://510kreport.com/company/3jt-enterprises)
- Roche Diagnostics Corp.: 3 (https://510kreport.com/company/roche-diagnostics)
- Cozart Bioscience, Ltd.: 3 (https://510kreport.com/company/cozart-bioscience)
- Labone, Inc.: 2 (https://510kreport.com/company/labone)
- Schering-Plough Healthcare Products, Inc.: 2 (https://510kreport.com/company/schering-plough-healthcare-products)

## Its most-cited devices
- K023487: Histofreezer Wart Removal System or Other Proprietary Name (2003), cited by 7
- K981341: STC Opiates Micro-Plate Eia (Orasure Application) (1998), cited by 5
- K992918: STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I (2000), cited by 4
- K972481: Auto-Lyte Cotinine Eia (1997), cited by 3
- K990877: Histofreezer Device (1999), cited by 3
- K993208: STC Methamphetamine Intercept Micro-Plate Eia, Model 1104I (2000), cited by 3

## Recent decisions
- DEN190025: OraQuick Ebola Rapid Antigen Test (Oct 10, 2019)
- P080027: Oraquick HCV Rapid Antibody Test (Jun 25, 2010)
- K060859: Compound W Freeze Off Wart Removal System (Jul 18, 2006)
- K023487: Histofreezer Wart Removal System or Other Proprietary Name (Mar 20, 2003)
- K013882: Oti Benzodiazepines Intercept Micro-Plate Eia Model #1110I (Apr 17, 2002)
- K020371: Uplink Test System (Apr 3, 2002)
- K011057: Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX (Jun 6, 2001)
- K002375: STC Cannabinoids Intercept Micro-Plate Eia, Model 1118I (Jan 26, 2001)

Source page: https://510kreport.com/company/orasure-technologies