North Dakota Department of Health Division of Laboratory Services
Welcome to the Division of Laboratory Services
Testing services support the investigation of disease outbreaks and provide direction for disease prevention and control activities. The laboratory serves in a reference capacity for local health units, private and community healthcare facilities and veterinary laboratories. Testing methods address specific public health issues such as emerging infectious diseases, antibiotic resistance and bioterrorism preparedness. Timely sample testing aides in the prevention and control of sexually transmitted diseases and many other diseases. Environmental hazard mitigation is accomplished through monitoring water and dairy products for compliance through mosquito surveillance activities and through support of investigational responses to natural or man-made disasters. In addition, outreach programs provide training in safety and laboratory testing methods and promote cooperative sharing with other agencies, both public and private.
Mission Statement
The mission of the North Dakota Department of Health (NDDoH) is to protect and enhance the health and safety of all North Dakotans and the environment in which we live. To accomplish our mission, the NDDoH is committed to improving the health status of the people of ND, improving access to and delivery of quality health care, preserving and improving the quality of the environment, promoting a state of emergency readiness and response, and achieving strategic outcomes within available resources.
New Memo's
SARS FDA EUA Information - November 30, 2020
BioFire FilmArray Respiratory Panel 2.1 PCR - September 23, 2020
BioFire FilmArray Gastrointestinal Panel PCR - September 8, 2020
Discontinuation of Tests - July 8, 2020
Abbott ID Now Update - May 21, 2020
Abbott Architect SARS-CoV-2 IgG Testing - May 14, 2020
SARS-CoV-2 (Novel Coronavirus)
North Dakota COVID-19 Guidance
SARS-CoV-2 Collection Instructions-Nasopharyngeal
SARS-CoV-2 Collection Instructions-Oropharyngeal
SARS-CoV-2 Hotline Number: 1-866-207-2880
Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
This table includes information about authorized SARS-CoV-2 molecular diagnostic tests. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories.
Date EUA Issued or
Last Updated | Entity | Diagnostic (Most Recent Letter of Authorization
& Date EUA Original Issue | Attributes | Authorization Documents |
| 10/16/2020 | Thermo Fisher Scientific, Inc. | TaqPath COVID-19 Combo Kit 03/13/2020 | Real-time RT-PCR, Home Collection | HCP, Patients, IFU |
| 10/05/2020 | Hologic, Inc. | Aptima SARS-CoV-2 assay 05/14/2020 | TMA, chemiluminescent, Pooling, Screening | HCP, Patients, IFU |
| 09/21/2020 | Cepheid | Xpert Xpress SARS-CoV-2 test 03/20/2020 | Real-time RT-PCR | HCP, Patients, IFU for Labs, IFU for Point-of Care |
| 07/30/2020 | Abbott Molecular | Abbott RealTime SARS-CoV-2 assay 03/18/2020 | Real-time RT-PCR | HCP, Patients, IFU |
| 05/01/2020 | BioFire Diagnostics, LLC | BioFire Respiratory Panel 2.1 (RP2.1) 05/01/2020 | RT, Nested multiplex PCR, Multi-analyte | HCP, Patients, IFU |
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas