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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 1 of 3

Device	Model / Reference	Registries	Class	Status
OraQuick TEST HIV PENTRU AUTOTESTARE	1001-0627	EUDAMED	IVD Annex II List A	Active
AUTOTEST PER L’HIV OraQuick	1001-0603U	EUDAMED	IVD Annex II List A	Active
AUTOTEST PER L’HIV OraQuick	1001-0603	EUDAMED	IVD Annex II List A	Active
AUTOTESTE DE VIH OraQuick	1001-0601	EUDAMED	IVD Annex II List A	Active
OraQuick HIV Self-Test	1001-0602	EUDAMED	IVD Annex II List A	Active
OraQuick HIV Self-Test	1001-0600U	EUDAMED	IVD Annex II List A	Active
Test OraQuick NA OBECNOŚĆ WIRUSA HIV DO SAMODZIELNEGO WYKONANIA	1001-0628	EUDAMED	IVD Annex II List A	Active
OraQuick SAMOTEST NA HIV	1001-0630U	EUDAMED	IVD Annex II List A	Active
OraQuick HIV Self-Test	1001-0629U	EUDAMED	IVD Annex II List A	Active
OraQuick HIV Self-Test	1001-0601U	EUDAMED	IVD Annex II List A	Active
Test OraQuick NA OBECNOŚĆ WIRUSA HIV DO SAMODZIELNEGO WYKONANIA	1001-0628U	EUDAMED	IVD Annex II List A	Active
OraQuick HCV Rapid Antibody Test	3001-1521	FDA UDI	Class II	Active
Histofreezer	1001-0295	FDA UDI	Class II	Active
Benzodiazepine Intercept 5 Plate Kit	1110IB	FDA UDI	Class II	Active
Cannabinoids Intercept 2 Plate Kit	1118IT	FDA UDI	Class II	Active
PCP Intercept 5 Plate Kit	1154IB	FDA UDI	U	Active
OraQuick Advance HIV 1/2 Kit Controls	1001-0077	FDA UDI	Class III	Active
Kit, MP Cotinine Serum 100 plate	1124EC	FDA UDI	Class I	Active
Cotinine Serum 5 Plate Kit	1124EB	FDA UDI	Class I	Active
Cotinine Serum 2 Plate Kit	1124ET	FDA UDI	Class I	Active
OraQuick In Home HIV Test (Not for Resale)	1001-0374	FDA UDI	Class II	Active
Methamphetamine Intercept 5 Plate Kit	1104IB	FDA UDI	Class II	Active
OraSure Quickflu Nasopharyngeal Wash / Aspirate	1001-0321	FDA UDI	Class I	Active
Benzodiazepine Intercept 100 Plate Kit	1110IC	FDA UDI	Class II	Active
Cocaine OraSure 5 Plate Kit	1122SB	FDA UDI	Class II	Active
OraSure HIV-1 Western Blot Kit	501-0000	FDA UDI	Class III	Unknown
Histofreezer	1001-0293	FDA UDI	Class II	Active
Histofreezer	1001-0375	FDA UDI	Class II	Active
Methadone Intercept 100 Plate Kit	1142IC	FDA UDI	Class II	Active
OraQuick HIV Self-Test	3001-3822UR	FDA UDI	Class II	Active
Cocaine OraSure 100 Plate Kit	1122SC	FDA UDI	Class II	Active
Cotinine OraSure 5 Plate Kit	1124SB	FDA UDI	Class I	Active
Cotinine OraSure 100 Plate Kit	1124SC	FDA UDI	Class I	Active
OraSure Oral Fluid Collection Device	3001-2870	FDA UDI	Class II	Active
Auto-Lyte	1224UL	FDA UDI	Class I	Active
OraQuick HIV Self-Test	3001-3822U	FDA UDI	Class II	Active
PCP Intercept 100 Plate Kit	1154IC	FDA UDI	U	Active
OraQuick HCV Rapid Antibody Test Kit Controls	1001-0182	EUDAMEDFDA UDI	Class II	Active
Q.E.D. Saliva Alcohol Test A150	60156	FDA UDI	Class II	Active
Methadone Intercept 2 Plate Kit	1142IT	FDA UDI	Class II	Active
Methamphetamine Intercept 2 Plate Kit	1104IT	FDA UDI	Class II	Active
OraQuick Advance Rapid HIV 1/2 Antibody Test	3001-1197	FDA UDI	Class III	Active
Opiates Serum 2 Plate Kit	1150ET	FDA UDI	Class II	Active
Intercept i2 Oral Fluid Collection Device	3001-2661	FDA UDI	Class I	Active
Cannabinoids Intercept 100 Plate Kit	1118IC	FDA UDI	Class II	Active
OraSure HIV-1 Oral Specimen Collection Device	HIV-1 Oral Specimen Collection Device	FDA UDI	Class III	Active
OraSure Quick Flu 22-Count Flu A + B Kit	1001-0320	FDA UDI	Class I	Active
PCP Intercept 2 Plate Kit	1154IT	FDA UDI	U	Active
Intercept	3001-2869	FDA UDI	Class II	Active
Methamphetamine Intercept 100 Plate Kit	1104IC	FDA UDI	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.