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OraSure Technologies, Inc.

United States·US-MF-000009941

Last updated September 17, 2026

About

OraSure Technologies is a global company that empowers the world to improve health and wellness by providing access to accurate, essential information.

From the manufacturer's own website. Source

Information

Country: United States
Address: 220, East First Street, Bethlehem, United States
Website: www.orasure.com
LinkedIn: linkedin.com/company/orasure-technologies
Facebook: facebook.com/orasure
Email: [email protected]
Phone: +1 610-882-1820
PRRC Contact: Tiffany Miller
EUDAMED SRN: US-MF-000009941
FDA FEI Number: 3003297763
DUNS Number: —

Catalogue (104)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Stc Cocaine Metabolite Micro-Plate Eia (orasure Device)	K982061	FDA 510(k)	Class II	Active
Stc Barbiturates Intercept Micro-Plate Eia, Model 1108i	K001976	FDA 510(k)	Class II	Active
Intercept i2	1001-0362	EUDAMED	Class A	Active
Oraquick Hcv Rapid Antibody Test	P080027	EUDAMEDFDA PMA	Class II	Active

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FDA Recalls (14)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 5, 2021	Z-1183-2021	—	terminated	Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance.
Jul 15, 2020	Z-3002-2020	—	terminated	Unit boxes not properly sealed
Jul 15, 2020	Z-3003-2020	—	terminated	Unit boxes not properly sealed
Jul 15, 2020	Z-3001-2020	—	terminated	Unit boxes not properly sealed
Jul 13, 2020	Z-2877-2020	—	terminated	Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
Jul 13, 2020	Z-2876-2020	—	terminated	Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
Dec 20, 2017	Z-1419-2018	—	terminated	The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
Nov 10, 2016	Z-0722-2017	—	terminated	Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
Jul 20, 2016	Z-2403-2016	—	terminated	Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.
Jan 15, 2016	Z-1509-2016	—	terminated	OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from one of their customers. The customer reported they received the Ora Quick Ebola Visual Reference Panel instead of an OraQuick HCV Visual Reference Panel.
Sep 8, 2008	Z-0478-2009	—	terminated	Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.
Sep 8, 2008	Z-0477-2009	—	terminated	Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.
Sep 8, 2008	Z-0481-2009	—	terminated	Readings, high: intermittent high absorbance readings. For further information, please contact the firm at 610-882-1820.
Sep 8, 2008	Z-0479-2009	—	terminated	Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.