OraSure Technologies, Inc.

Item Number 1001-0343, Lot # 6648737

Immunology and Microbiology Devices

3

No

Nationwide Distribution -- AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MI, MO, MT, NC, ND, NE, NH, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, and WI.

OraQuick HCV Visual Reference Panel || Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.

Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.

Distributed to one customer only in US state of Georgia.

OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.

Lot # 6654085

Clinical Chemistry and Clinical Toxicology Devices

2

No

Distributed to KS, and VA

Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) || Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.

Lot Number: 0006661251, Expiration date: 02/28/2018

Clinical Chemistry and Clinical Toxicology Devices

2

No

Distributed to 2 consignees in KS.

Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000

Product number 61456. Lot numbers 6604829, 6604836, 6606036, 6606585, and 6606591

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution --- USA including states of AZ, CA, CT, DE, FL, GA, ID, KS, KY, MA, MD, MI, NC, NH, NV, NY, PA, VA, and WY, and countries of United Kingdom, Italy, Germany, and Canada.

Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Plate EIA kit.