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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 2 of 3

Device	Model / Reference	Registries	Class	Status
Histofreezer	1001-0336	FDA UDI	Class II	Active
Histofreezer	1001-0294	FDA UDI	Class II	Active
Cannabinoids Intercept 5 Plate Kit	1118IB	FDA UDI	Class II	Active
Auto-Lyte	1224UM	FDA UDI	Class I	Active
Amphetamine Intercept 5 Plate Kit	1103IB	FDA UDI	Class II	Active
Cocaine Intercept 5 Plate Kit	1122IB	FDA UDI	Class II	Active
Benzodiazepine Intercept 2 Plate Kit	1110IT	FDA UDI	Class II	Active
Barbiturates Intercept 100 Plate Kit	1108IC	FDA UDI	Class II	Active
OraQuick Ebola Rapid Antigen Test	3001-2940	FDA UDI	Class II	Active
Cocaine Intercept 100 Plate Kit	1122IC	FDA UDI	Class II	Active
Opiates Intercept 100 Plate Kit	1150IC	FDA UDI	Class II	Active
Barbiturates Intercept 5 Plate Kit	1108IB	FDA UDI	Class II	Active
OraQuick In Home HIV Test, Pharmacy	1001-0528	FDA UDI	Class II	Active
Opiates Serum 5 plate Kit	1150EB	FDA UDI	Class II	Active
Rite Aid	0361539	FDA UDI	Class II	Active
Cocaine Intercept 2 Plate Kit	1122IT	FDA UDI	Class II	Active
Barbiturates Intercept 2 Plate Kit	1108IT	FDA UDI	Class II	Active
Amphetamine Intercept 100 Plate Kit	1103IC	FDA UDI	Class II	Active
OraSure QuickFlu Positive and Negative Control Kit	1001-0323	FDA UDI	N/A	Active
Methadone Intercept 5 Plate Kit	1142IB	FDA UDI	Class II	Active
Opiates Intercept 5 Plate Kit	1150IB	FDA UDI	Class II	Active
OraQuick In Home HIV Test	1001-0340	FDA UDI	Class II	Active
Stc Cannabinoids Micro-Plate Eia	K973750	FDA 510(k)	Class II	Active
Auto-Lyte Benzodiazepines Eia Model Number 1210u	K982831	FDA 510(k)	Class II	Active
Histofreezer/ 17% Salicylic Acid-Verruca Plantaris	K980739	FDA 510(k)	Class II	Active
Compound W Freeze Off Wart Removal System	K060859	FDA 510(k)	Class II	Active
Stc Opiates Micro-Plate Eia (orasure Application)	K981341	FDA 510(k)	Class II	Active
Stc Methadone Intercept Micro-Plate Eia, Model 11421	K002010	FDA 510(k)	Class II	Active
Auto-Lyte Cocaine Metabolite Eia, Model # 1222u	K982759	FDA 510(k)	Class II	Active
Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-Xxxx	K011057	FDA 510(k)	Class II	Active
Histofreezer Verruca Plana	K971392	FDA 510(k)	Class II	Active
Stc Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103i	K992918	FDA 510(k)	Class II	Active
Stc Methamphetamine Micro-Plate Eia	K972989	FDA 510(k)	Class II	Active
Uplink Test System	K020371	FDA 510(k)	Class II	Active
Stc Methamphetamine Intercept Micro-Plate Eia, Model 1104i	K993208	FDA 510(k)	Class II	Active
Histofreezer Wart Removal System Or Other Proprietary Name	K023487	FDA 510(k)	Class II	Active
OraQuick Ebola Rapid Antigen Test	DEN190025	EUDAMEDFDA 510(k)	Class II	Active
Micro-Plate Cotinine Eia	K974234	FDA 510(k)	Class I	Active
Auto-Lyte Pcp Eia, Model #1254u	K982801	FDA 510(k)	U	Active
Auto-Lyte Barbiturates Eia	K982745	FDA 510(k)	Class II	Active
Auto-Lyte Cotinine Eia	K972481	FDA 510(k)	Class I	Active
Histofreezer Device	K982358	FDA 510(k)	Class II	Active
Stc Cocaine Metabolite Micro-Plate Eia	K973651	FDA 510(k)	Class II	Active
Histofreezer Device	K990877	FDA 510(k)	Class II	Active
Stc Cannabinoids Intercept Micro-Plate Eia, Model 1118i	K002375	FDA 510(k)	Class II	Active
Oti Benzodiazepines Intercept Micro-Plate Eia Model #1110i	K013882	FDA 510(k)	Class II	Active
Stc Pcp Intercept Micro-Plate Eia, Model 11541	K000399	FDA 510(k)	U	Active
Stc Auto-Lyte Urinary Glucose Assay	K962435	FDA 510(k)	Class II	Active
Micro-Plate Cotinine Eia	K974534	FDA 510(k)	Class I	Active
Cocaine Metabolite Intercept Micro-Plate Eia	K001197	FDA 510(k)	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.