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INFORMATION FOR

Designated Labs by State

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The SalivaDirect™ team at the Yale School of Public Health have designated the following laboratories as authorized to offer the SalivaDirect™ test under our EUA 202097. This list will be regularly updated as more laboratories throughout the country become designated. These laboratories may not be able to test individuals directly, but can point you to providers and healthcare facilities that are providing the test. Please contact the nearest designated laboratory for more information on how to get tested with SalivaDirect.

*Special Note: not all labs that are designated are listed on the site

Designated labs by state

Arizona (AZ)

VACC Laboratories

Contact: Vincent Aoki, PhD

4582 N 1st Ave, Suite 190 Tucson, AZ 85718

Phone: 520-501-9100

Email: Info@vacclabs.com

Website: https://www.vacclabs.com/


Premier Lab Solutions

3440 N 16th Street Phoenix , AZ 85016-7125

Phone: 602-441-2808

Email: msrivastava@premierlabsolutions.com

Website: https://premierlabsolutions.com//

California (CA)

Aptitude Clinical Diagnostics

Contact: Jackson Gong

125 Cremona Drive, STE 100, Goleta, CA 93117

Phone: 415-233-4292

Email: jackson@aptitudemedical.com

Website: aptitudeclinical.com


Arbor Vita Corporation

Contact: Peter Lu M.D.

48371 Fremont Blvd Suite 101, Fremont, CA 94538

Phone: 650-793-3686; 408-585-3902

Email: peter.lu@arborvita.com

Website: https://www.arborvita.com/covid-19-testing


BiomeDNA Inc.

Contact: You Chen

6331 Nancy Ridge Dr, San Diego, CA 92121

Phone: 858-203-7944

Email: biome6331@gmail.com

Website: biomedna.com


Breakthrough Genomics

Contact: Laura Li

25 Mauchly, #313 Irvine, CA 92618

Phone: 310-429-3165

Email: info@btgenomics.com

Websites: www.btgenomics.com; www.mycovscan.com


Clinomics USA Inc.

Contact: Sumin Choi

5555 Oberlin Drive, Suite 110 San Diego, CA 92121

Phone: 917-617-9481

Email: smchoi@clinomics.com

Website: https://www.clinomics.com/en/main


First Rate Lab

23276 S Pointe Suite 101 Laguna Hills, CA 92653

Phone: 949-317-0637

Email: clientservices@firstratelab.com

Website: https://firstratelab.com/


Flow Health Laboratories LLC

8627 Washington Blvd, Culver City, CA 90232

Contact: Helmie Teketay

Phone: 320-223-9727

Email: helmie@flowhealth.com

Website: https://www.flowhealth.com/


Full Stack Bio, LLC

Contact: Spencer Hantula

1124 W. Carson St. Torrance, CA 90502

Phone: 310-618-9156

Email: shantula@fullstackbio.com

Website: https://www.fullstackbio.com/


HealthQuest Esoterics

Contact: Arman Sepetjian

6 Bendix, Irvine, CA 92618

Phone: 951-403-5277

Email: Arman@hqesoterics.com

Website: https://www.hqesoterics.com/


NKGen Biotech

Contact: Lucia Hui

3001 Daimler St, Santa Ana, CA 92705

Phone: 949-396-6830

Email: clientservices@nkgenbiotech.com

Website: https://nkgenbiotech.com/


Nexsun Diagnostic Laboratories, LLC

15735 Barranca Parkway, Suite A-110 Irvine, CA 92618


renegade.bio

Contact: Limor Allen

5700 Martin Luther King Jr Way Oakland #1521, CA 94609

Phone: 415-308-1416

Email: limor@renegade.bio


SeqMatic LLC

Contact: Victor Hum

44846 Osgood Rd, Fremont, California 94539

Phone: 510-474-2800

Email: victor.hum@seqmatic.com

Website: www.seqmatic.com


Simple HealthKit

46421 Landing Pkwy, Fremont, CA 94538

Contact: Jurek Majka

Phone: 650-393-9852

Email: jurek@simplehealthkit.com

Website: https://www.simplehealthkit.com/


Test Well

Contact: Charles Boldwyn

1233 Ski Run Blvd. #4, South Lake Tahoe, California 96150 *

Phone: 530-322-8717

Email: info@testwell.clinic

Website: https://www.testwell.clinic/

* This lab has collection sites in CA and NV. Check out the lab website for more details.


US Specialty Labs

Contact: Bryan Andrus

11588 Sorrento Valley Road, San Diego, California 92121

Phone: 858-345-1109; 858-209-2300

Email: Bryan@usspecialtylabs.com

Website: usspecialtylabs.com

Colorado (CO)

Elevation Diagnostics

Contact: Kristen Gracom

2115 N Scranton St, Suite 3040A Aurora, CO 80045

Phone: 800-440-5184 x701

Email: laboratory@elevationdiagnostics.com

Website: www.elevationdiagnostics.com

Connecticut (CT)

Corium Diagnostics

Contact: Gary A. Letts, MD

148 East Avenue, Suite 2D, Norwalk CT, 06851-5726

Phone: 203-348-7546

Email: Info@Coriumdx.com

Website: https://www.covidtestct.com/


Danbury Hospital

Contact: Dr. Gunjan Gupta, MD

24 Hospital Avenue Danbury, Connecticut, 06810

Phone: 203-739-7306

Email: gunjan.gupta@nuvancehealth.org

Website: https://www.danburyhospital.org/departments/pathology-and-laboratory-services-at-danbury-hospital/contact-us


Yale Pathology Clinical Molecular Diagnostic Lab

Contact: Stephanie Weirsman, Physician Liaison, Yale Medicine Pathology

310 Cedar Street, New Haven CT 06510

Phone: 203-464-5518

Email: yalepathologylabs@yale.edu

Website: https://medicine.yale.edu/pathology/clinical/mdx/salivadirect/

Delaware

Delaware State University Molecular Diagnostics Laboratory

Contact: Derrick Scott

3931 Kirkwood Highway, Wilmington DE, 19808

Email: Dcscott@desu.edu


RSM Diagnostics Lab LLC

Contact: Rajesh Gautam

2500 Grubb Rd, Suite 120, Wilmington DE, 19808

Phone: 302-592-4106

Email: raj@rsmdiagnosticslab.com

Website: https://www.rsmdiagnosticslab.com/

Florida (FL)

Access Medical Labs

Contact: Andrew O’Connor

5151 Corporate Way, Jupiter, FL 33458

Phone: 866-720-8386

Email: Teamcovid19@accessmedlab.com


Clarity Lab Solutions

1060 Holland Drive, Suite A, Boca Raton, FL 33487


Dynix Diagnostix

Contact: Anthony Galgano

2260 N US Hwy 1, Fort Pierce, Fl. 34946

Phone: 772-324-6430

Email: Anthony@dynixdiagnostix.com

Website: www.dynixdiagnostix.com


Minute Lab

Contact: Treina Johnson

9716 Pines Blvd Pembroke Pines, FL 33024

Phone: 954-931-4214

Email:minutelabtesting@gmail.com

Website:https://minutelabtesting.com/


Number One Lab

Contact: Claudia Wickard

586 NW 27th Street, Miami, Florida 33125

Phone: 256-605-6382

Email: claudia@numberonelab.com


PGN Lab

Contact: Kayla Bradford

7811 SW Ellipse Way #17, Stuart, Florida 34997

Phone: 561-308-9342

Email: kayla@ellipsedx.com

Website: www.ellipsedx.com


Protean BioDiagnostics Inc.

Contact: Anthony Magliocco

6555 Sanger Rd, Suite 232, Orlando, Florida 32827

Phone: 813-817-2042

Email: magliocco@proteanbiodx.com

Website: https://www.proteanbiodx.com

Georgia (GA)

Emory Univ (ELIAD)

Contact: John Roback, MD PhD

101 Woodruff Circle, Atlanta, Georgia, 30322

Phone: 404-788-5655

Email: jroback@emory.edu


Global 7 Diagnostics

Contact: Ozaer Faroqui

3240 Pointe Parkway, Suite #200, Norcross, GA 30092

Phone: 470-300-1191

Email: info@global7dx.com


LifeHope Labs, LLC

5009 Rosewell Rd, Sandy Springs, Georgia 30342

Website: https://oxy-genlab.com/


myGenomics, LLC

Contact: Dr. Shoeb Ahmad

11535 Park Woods Circle, Suite E, Alpharetta, Georgia, 30005

Phone: 855-647-4363

Email: info@mygenomics.com

Website: https://www.mygenomics.com/booking-calendar-for-covid-testing/


Ocean Biosciences LLC

1369 Spring St NW, Atlanta GA 30309

Contact: Helmie Teketay

Phone: 320-223-9727

Email: helmie@flowhealth.com

Website: https://www.flowhealth.com/


Oxy-Gen Laboratory

5680 Oakbrook Pkwy Ste 100, Norcross, Georgia 30093-1841

Website: https://oxy-genlab.com/


PCG Molecular LLC

Contact: Armando Moncada, MD FCAP

3140 Ronald Reagan Blvd, Cumming, GA 30041

Mailing Address: 5485 Bethleview Rd. Ste 360-366, Cumming, GA 30040

Phone: 404-301-4460

Email: amoncada@pcgmolecular.com

Website: www.pcgmolecular.com


Viral Solutions LLC

Contact: Dr. Anthony Luyai

2900 Chamblee Tucker Rd, Atlanta GA 30341

Phone: 404-542-7151

Email: anthony@viralsolutionsga.com

Website: https://viralsolutions.com/

Idaho (ID)

Boise State University

Contact: Stephanie Hudon, PhD

2133 W Cesar Chavez Ln, Science 239 Boise, ID 83725

Phone: 208-995-3765

Email: stephaniehudon@boisestate.edu

Illinois (IL)

ALC Diagnostics

2434 East Dempster Street Suite 109, Des Plaines, IL 60016

Phone: 847-636-7678

Website: https://alcdx.com/


American Molecular Laboratories Inc.

Contact: Sam Zhang

50 Lakeview Pkwy Suite 127 Vernon Hills, IL 60061

Phone: 847-6281-7670

Email: am@amlaboratories.com

Website: https://www.amlaboratories.com/


Neelyx Labs

Contact: Shyam Saladi

330 Georgetown Square, Wood Dale, Illinois 60191

Phone: 630-422-3904

Email: laboperations@neelyx.com

Website: www.neelyx.com


Premier Health Network LLC

Contact: Christopher Bradley

1301 E 47th St, Bldg 2 Chicago, IL 60653

Phone: 219-805-2083

Email: cbpremierhealth@gmail.com

Website: http://premierucchicago.com


PRISM Health Lab

Contact: John Kolozak

515 N. Dearborn St Chicago, IL 60654

Phone: 646-610-1493

Email: johnk@prismhealthlab.com

Website: Affordable Labs and Testing | Prism Health Lab


Simple Laboratories

Contact: Marlet Sinigiuan

7444 W Wilson Ave, Harwood Heights, Illinois 60706

Phone: 773-775-6697

Email: marlet.siniguian@SimpleLaboratories.com

Website: SimpleLaboratories.com


Tempus Labs

Contact: Ben Howard

600 W Chicago Ave Ste #510, Chicago, IL 60654

Phone: 888-514-4187

Email: covidsupport@tempus.com

Website: https://www.tempus.com/infectious-disease/

Iowa (IA)

Health Research Institute

Contact: John Fagan, PhD

505 Dimick Drive (physical Address), PO Box 370 (Address for US Postal Service) Fairfield, Iowa 52556

Phone: 641-451-5454

Email: John.fagan@hrilabs.org

Kansas (KS)

Wichita State University Molecular Diagnostics Lab

Contact: Sarah Nickel

4174 S. Oliver, Bld. #174H, Wichita, KS 67210

Phone: 316-978-8600

Email: sarah.nickel@wichita.edu

Kentucky (KY)

Pearl Medical Practice, PLLC

Contact: William F. Connor, Jr. "Chip"

2202 Buechel Avenue, Louisville, KY 40218

Phone: 502-456-0494

Email: wconnor@pearlgeriatrics.com

Louisiana (LA)

Covalent Laboratories LLC

Contact: Mandolin Whitney

8000 Innovation Drive Baton Rouge Louisiana, 70820

Phone: 504-208-0715

Email: mandolin@covalent-labs.com


Louisiana Animal Disease Diagnostic Laboratory (LADDL)

Contact: Udeni Balasuriya

River Road, Room # 1043 Baton Rouge Louisiana, 70803

Phone: 225-578-9775

Email: balasuriya1@lsu.edu

Website: lsu.edu/vetmed/laddl/

Maryland (MD)

Accelevir Diagnostics

Contact: Miriam Hays

701 E Pratt St. Suite 4016 Baltimore, MD 21202

Phone: 443-887-4090

Email: customerservice@accelevir.com

Website: https://www.accelevirdx.com/


CIAN Diagnostics

Contact: Sam Mullapudi

5330 Spectrum Drive Suite I, Frederick, Maryland 21703

Phone: 240-422-4164

Email: sam@ciandx.com

Website: www.ciandx.com


Patriot Medical Laboratories dba CIAN Diagnostics

Contact: Sam Mullapudi

5330 Spectrum Drive, Suite I Frederick, MD 21703

Phone: 240-422-4164

Email: sam@ciandx.com

Website: https://ciandx.com/


Psomagen

Contact: Ji won Lee

1330 Piccard Dr. ste 103 Rockville, MD 20850

Phone: 301-251-1007

Email: inquiry@psomagen.com

Website: www.psomagen.com

Massachusetts (MA)

Genomic Expression

Contact: Gitte Pedersen, CEO

100 Cumming Center, Suite 451C, Beverly, MA 92617

Phone: 617-300-8888

Email: Covid19@genomicexpression.com

Minnesota (MN)

Hennepin Healthcare System / Hennepin County Medical Center / HCMC

701 Park Avenue Minneapolis, MN 55415

Email: labOutreach@hcmed.org


University Of Minnesota

Contact: Kenny Beckman

2231 6th Street SE Minneapolis Minnesota, 55455

Phone: 612-626-2985; 651-666-7842


Valley Medical Laboratory

Contact: Ashwin George, MD

2428 East 117th Street, Burnsville, MN, 55337

Email: ageorge@valleymedical.com

Website: https://www.valleymedical.com/

Missouri (MO)

Cox Medical Center South Laboratory

Contact: Louie Quinones

3801 S National Ave, Springfield, MO 65807

Phone: 417-269-0623

Email: louie.quinones@coxhealth.com

Website: https://www.coxhealth.com/


Environmental Health Laboratories

Contact: Jennifer Western

6121 North Hanley Rd, Berkeley, Missouri 63134

Phone: 314-615-8324

Email: jwestern@stlouisco.com

Website: https://stlcorona.com/covid-19-testing/


Saint Louis County Dept. of Public Health, Environmental Health Laboratories

Contact: Jennifer Western

6121 North Hanley Rd, Berkeley, MO 63134

Phone: 314-615-8324

Email: jwestern@stlouisco.com

Website: https://stlcorona.com/covid-19-testing/

Montana (MT)

Shodair Children's Hospital Department of Medical Genetics

Contact: Corbin Schwanke

2755 Colonial Dr. Helena Montana, 59601

Phone: 406-444-7582

Email: cschwanke@shodair.org

Website: https://shodair.org/genetics/laboratory/

Nebraska (NE)
University of Nebraska-Lincoln (Veterinary Diagnostic Center)

Contact: Dr. Bruce Brodersen

4040 East Campus Loop North Lincoln Nebraska, 6858

Phone: 402-472-1434

Email: Vdc2@unl.edu

Website: https://vbms.unl.edu/nvdc

Nevada (NV)

Test Well

Contact: Charles Boldwyn

3324 Coliseum Way, Reno, NV 89502

Phone: 530-322-8717

Email: info@testwell.clinic

Website: https://www.testwell.clinic/

New Hampshire (NH)

Cheshire Medical

Contact: Claire Fabian, MD

520 Court St Keene, New Hampshire, 03431

Phone: 603-354-5454 ext 2293

Email: cfabian@cheshire-med.com

Website: cheshiremed.org

New Jersey (NJ)

Capital Health Laboratory

Contact: Suvas Desai

152 Rt 35 Keyport, New Jersey 07735

Phone: 732-642-1133

Email: sdesai@capitalhealthlab.com


Histopathology Services (Pathline)

Contact: Steve Pickens

535 E Crescent Ave, Ramsey NJ 07446

Phone: 201-661-7280

Email: spickens@pathlinelabs.com

Website: https://pathlinelabs.com/


Lab Turbo Biotech

12 Roszel Rd B102, Princeton, NJ 08540

Phone: 609-878-2889

Email: info@labturbo.com

Website: https://labturbobiotech.com


SiParadigm LLC

Contact: Alireza Zarineh

25 Riverside Dr, Suite #2, Pine Brook, NJ, 07058

Phone: 201-599-9044 ext: 4297

Email: alireza.zarineh@siparadigm.com

Website: www.siparadigm.com


Suretox Laboratory

Contact: Aleksandra Bocheska

241 Molnar Dr. Unit A1 Elmwood Park New Jersey 07407

Phone: 201-791-7293

Email: Aleksandra@suretoxlab.com

Website: suretoxlab.com

New York (NY)

AlbaNYlabs LLC

Contact: Dr. Sumanta Goswami

150 New Scotland Ave, Albany, New York 12208

Phone: 347-613-3322

Email: sumanta.goswami@albanylabs.com

Website: www.albanylabs.com


Eastgene Laboratories

Contact: Dr. Ruliang Xu

42-18 162nd Street Flushing New York, 11358

Phone: 718-463-4888; 917-388-0793

Email: service@eastgene.com

Website: www.eastgene.com


Mirimus, Inc.

760 Parkside Ave., Suite 206, Brooklyn, NY 11226

Phone: 929-377-3744

Email: testing@mirimus.com


North Carolina (NC)

Communitylab

Contact: Marcos Romero

2 Trident Dr. Arden, North Carolina 28704

Phone: 828-279-7659; 866-670-5705

Email: mhromero@sanescohealth.com

Website: communitylabwnc.com

Ohio (OH)

Battelle Memorial Institute

Contact: Jeanne Ohrnberger

1425 Plain City Georgesville Rd NE, West Jefferson, OH 43162

Phone: 614-424-5227

Email: lab@battelle.org

Oregon (OR)

Rize Lab

Location: 545 SW 2nd St Suite 201 Corvallis, OR 97333

Phone: 541-368-3050

Email: community@rizelab.com

Pennsylvania (PA)

Advaite, Inc.

Contact: Karthik Musunuri

365 Phoenixville Pike, Malvern, Pennsylvania 19355

Phone: 484-842-0220

Email: Info@advaite.com

Website: www.advaite.com


Carnegie Mellon University PTC

Contact: Florent Letronne

5000 Forbes Ave, Pittsburgh, PA 15219

Phone: 412-268-1927

Email: fletronn@andrew.cmu.edu


MedArbor Diagnostics

200 Rittenhouse Circle Suite 1E, Bristol, PA 19007

Phone: 888-590-0808

Email: info@medarbor.com

Website: http://www.medarbor.com/


Religen Inc

Contact: Phillip Martinez

5110 Campus Drive Ste 120 Plymouth Meeting Pennsylvania, 19462

Phone: 214-802-9938

Email: phillip.martinez@religendx.com

Website: https://religendx.com/


Signature Dx Labs

Contact: JP Caldwell

1501 Preble Ave, Pittsburgh, Pennsylvania 15233

Phone: 412-677-0664

Email: info@signaturedx.com

Website: www.sdx-labs.com

South Carolina (SC)

Nephron SC, Inc.

Contact: David Bastian

4500 12th Street Extension, West Columbia, SC 29172

Phone: 803-626-2678

Email: dbastian@nephronpharm.com

Tennessee (TN)

EDP Biotech Corporation

6701 Baum Drive Suite 110, Knoxville, TN 37919

Phone: 865-299-6250

Email: info@edpbiotech.com

Website: http://www.edpbiotech.com/

Texas (TX)

APC Health LLC

Contact: Rohan Nath

2825 Miller Ranch Road, Suite 225, Pearland, TX 77584

Phone: 281-240-0974 Ext. 250

Email: rnath@apchealth.net


Aperture Next-Gen Laboratory

Contact: JR Davie, MD

609 W 15th St #210 Plano TX, 75075

Phone: 877-433-7284

Email: Info@angletest.com

Website: https://www.angletest.com


Auspicious Laboratory

Contact: Jianghong Jiang

3707 Westcenter Dr Suite 100 Houston, TX 77042

Phone: (713) 266-0808

Email: jjiang@auspiciouslab.com

Website: https://www.auspiciouslab.com/


BioExcel Diagnostics

Contact: Mehdi Dehghani

2636 South Loop W, Ste 110 Houston, TX 77054

Phone: 832-425-5042

Email: mdehghani@bioexceldx.com

Website: www.BioExceldx.com


Direct Diagnostics

Contact: Pravin Shrestha, PhD

3055 Hunter Rd, San Marcos, TX 78666

Phone: 512-245-6422

Email: pravin@directdiagnostics.com

Website: directdiagnostics.com


Gene by Gene

Contact: Jamie Blahut

1445 North Loop West Suite 760, Houston, TX 77008

Phone: 346-326-7873 (Ext 2250)

Email:covid19@genebygene.com

Website:https://genebygene.com/


Genview Diagnosis Inc (Site 2)

Contact: Dr. Bosong Dai

5252 Hollister St. Suite 520, Houston TX 77040

Phone: 281-513-7010

Email:genviewinfo@gmail.com

Website:https://i24test.com/


Endeavor DNA Inc.

Contact: Daniel Slowinski

6955 N Mesa St Suite 109 El Paso Texas, 79912

Phone: 915-519-1600

Email: info@endeavordna.com

Website: www.endeavordna.com


Onpoint Lab

Contact: Zoya Momin

1229 Creekway Dr. Ste # 103, Sugar Land, TX 77487

Phone: 832-939-8480

Email: zmomin@onpointlab.com

Website: onpointlab.com


Recon Diagnostics Inc.

Contact: Allison Seeger

3810 Medical Parkway Suite 253, Austin, TX 78756

Phone: 512-939-8849

Email: aseeger@recondx.com

Website: https://www.recondiagnostics.com


Supreme Medical Labs

Contact: Will Benton

3803 Parkwood Blvd Suite 400, Frisco, TX 75034

Phone: 469-850-0548

Email:William@precisionlabmgmt.com

Website:https://suprememedlabs.com/

Utah (UT)

Nomi Health Lab Services

Contact: Jon Ahlstrom

Building B, Suite 120, Salt Lake City, Utah 84124

Phone: 801-822-8615

Email: jon.ahlstrom@nomihealth.com

Website: https://nomihealth.com/

Virginia (VA)

Athari Biosciences, Inc.

45925 Horseshoe Dr., Suite 170, Sterling VA, 20166

Phone: 703-444-8000

Email: testing@athari.bio

Website: www.athari.bio


Howard Hughes Medical Institute Clinical Laboratory

Contact: Meghan Seltzer

19700 Helix Drive Ashburn VA, 20147

Phone: 571-465-0591

Email: TestingLab@janelia.hhmi.org


Polaris Genomics

Contact: Anne Naclerio, MD MPH

11100 Endeavor Court, Manassas, VA 20109

Phone: 571-229-9668

Email: Anne@polarisgenomics.com

Website: https://polarisgenomics.com/covid-testing/


United Medical Laboratory

1980 Gallows Rd, Vienna, VA 22182

Contact: Helmie Teketay

Phone: 320-223-9727

Email: helmie@flowhealth.com

Website: https://www.flowhealth.com/

Washington (WA)

Altius Diagnostics Laboratory

Contact: Eric Lo

12100 Northup Way Suite A Bellevue Washington, 98005

Phone: 425-341-4818

Email: info@altiusdiagnostics.com

Website: Altiusdiagnostics.com


Lynx Healthcare

Contact: Jessica Butts

12709 E. Mirabeau Pkwy Building A Suite 300, Spokane Valley, WA 99216

Phone: 509-591-0070; 509-942-8481

Email: jessica@lynx.healthcare

Website: www.lynx.healthcare


Northwest Pathology dba Northwest Laboratory

Contact: Jennifer Bull

3548 Meridian St. Bellingham, WA 98225

Phone: 360-527-4580

Email: jennifer.bull@nwpathology.com

Website: https://www.averodx.com/?welcome=northwest

West Virginia (WV)

QLabs Inc

Contact: Mary Collins

312 MacCorkle Avenue SE, Charleston, WV 25314

Phone: 304-926-0565

Email: Mary.Collins@QLabs-Inc.com

Website: https://www.qlabs-inc.com/

Wisconsin (WI)

Marquette University Department of Clinical Laboratory Science

Contact: Erik Munson

560 North 16th Street Milwaukee Wisconsin, 53233

Phone: 414-288-5848

Email: erik.munson@marquette.edu

Important Regulatory Information about SalivaDirect™

SalivaDirect™has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.