Entities wishing to perform waived COVID-19 testing at their facility must apply for Limited Service Laboratory registration. This testing may include molecular, antigen or antibody testing.
When completing the Limited Service Laboratory Initial Application DOH-4081 or adding this testing to an existing registration using the Add and/or Delete Test Procedures Form, you must indicate the type of COVID-19 test (i.e., COVID-19 Antigen, COVID-19 Molecular, or COVID-19 Antibody)
The current list of devices approved for use in limited service laboratories is (this list will be revised as new tests are approved):
COVID-19 Antigen
*Devices marked with an asterisk require the addition of more than COVID-19 Antigen (e.g. influenza and/or RSV).
- Abbott BinaxNOW COVID-19 Ag Card
- Abbott BinaxNOW COVID-19 Ag Card Home Test
- Abbott BinaxNOW COVID-19 Antigen Self Test
- Access Bio CareStart COVID-19 Antigen Test
- Access Bio CareStart COVID-19 Antigen Home Test
- ACON Laboratories Flowflex COVID-19 Antigen Home Test
- ACON Laboratories Flowflex COVID-19 Antigen Rapid Test
- Advin COVID-19 Antigen Test @Home
- Azure Biotech Inc. Fastep COVID-19 Antigen Home Test
- Azure Biotech Inc. Fastep COVID-19 Antigen Pen Home Test
- Becton, Dickinson (BD) Veritor System for Rapid Detection of SARS-CoV-2
- Becton, Dickinson (BD) Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B*
- Beijing Hotgen Biotech Co., Ltd. Hotgen COVID-19 Antigen Home Test
- Biosynchronicity C-Sync COVID-19 Antigen Test
- BioTeke USA Bio-Self COVID-19 Antigen Home Test
- CorDx COVID-19 Ag Test
- CTK Biotech, Inc. ImmuView COVID-19 Antigen Home Test
- DiaTrust COVID-19 Ag Home Test from Celltrion USA
- DiaTrust COVID-19 Ag Rapid Test from Celltrion USA
- Ellume COVID-19 Home Test
- ellume.lab COVID Antigen Test
- Genabio COVID-19 Rapid Self-Test Kit
- GenBody COVID-19 Ag
- GenBody COVID-19 Ag Home Test
- iHealth COVID-19 Antigen Rapid Test
- iHealth COVID-19 Antigen Rapid Test Pro
- Immunostics Inc. Swab-N-Go Home Test COVID-19 Ag
- InBios International, Inc. SCoV-2 Ag Detect Rapid Test
- InBios International, Inc. SCoV-2 Ag Detect Rapid Self-Test
- LumiraDx SARS-CoV-2 Ag Test
- MaximBio ClearDetect COVID-19 Antigen Home Test
- Mologic, Inc. COVI-Go SARS-CoV-2 Ag Self-Test
- Nano-Ditech Corp. Nano-Check COVID-19 Antigen Test
- Nano-Ditech Corp. Nano-Check COVID-19 Antigen At-Home Test
- Oceanit Foundry LLC ASSURE-100 Rapid COVID-19 Test
- Oceanit Foundry LLC ASSURE-100 Rapid COVID-19 Home Test
- OraSure Technologies, Inc. InteliSwab COVID-19 Rapid Test Pro
- OraSure Technologies, Inc InteliSwab COVID-19 Rapid Test Rx
- OraSure Technologies, Inc InteliSwab COVID-19 Rapid Test
- OSANG OHC COVID-19 Antigen Self Test
- PHASE Scientific International, Ltd. INDICAID COVID-19 Rapid Antigen Test
- PHASE Scientific International, Ltd. INDICAID COVID-19 Rapid Antigen At-Home Test
- Princeton BioMeditech Corp. Status COVID-19/Flu A&B*
- Princeton BioMeditech Corp. Status COVID-19 Antigen Rapid Test for Home Use
- Princeton BioMeditech Corp. ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test
- Qorvo Biotechnologies, LLC. Omnia SARS-CoV-2 Antigen Test
- Quidel Sofia SARS Antigen FIA
- Quidel Sofia 2 Flu + SARS Antigen FIA*
- Quidel QuickVue SARS Antigen Test
- Quidel QuickVue At-Home COVID-19 Test
- Quidel QuickVue At-Home OTC COVID-19 Test
- Salofa Oy Sienna-Clarity COVID-19 Antigen Rapid Test Cassette
- SD Biosensor Pilot COVID-19 At-Home Test
- SD Biosensor STANDARD Q COVID-19 Ag Test 2.0
- Sekisui OSOM COVID-19 Antigen Home Test
- Sekisui OSOM COVID-19 Antigen Rapid Test
- Siemens Healthineers CLINITEST Rapid COVID-19 Antigen Self-Test
- Watmind USA Speedy Swab Rapid COVID-19 Antigen Self-Test
- Xiamen Boson Biotech Rapid SARS-CoV-2 Antigen Test Card
COVID-19 Molecular
**Devices marked with an asterisk require the addition of more than COVID-19 Molecular (e.g. influenza and/or RSV). Please contact us if adding the BioFire Panel.
- Abbott ID NOW COVID-19
- Abbott ID NOW COVID-19 2.0
- ADL Diagnostics, Inc. The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector
- Aptitude Medical Systems Inc. Metrix COVID-19 Test
- BioFire Diagnostics Respiratory Panel 2.1 EZ**
- Cepheid Xpert Xpress SARS-CoV-2 test
- Cepheid Xpert Xpress CoV-2 plus
- Cepheid Xpert Xpress CoV-2/Flu/RSV plus**
- Cue Health COVID-19 Test
- Cue Health COVID-19 Test for Home and Over the counter (OTC) Use
- DxLab COVID-19 Test
- Lucira CHECK-IT COVID-19 Test Kit
- Lucira COVID-19 All-In-One Test Kit
- Lucira COVID-19 & Flu Test**
- Lucira COVID-19 & Flu Home Test**
- Mesa Biotech (Thermo) Accula SARS-CoV-2
- MicroGEM Sal6830 SARS-CoV-2 Saliva Test
- Minute Molecular Diagnostics, Inc. DASH SARS-CoV-2/S Test
- Roche Molecular cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
- Roche Molecular cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System**
- TangenDx SARS-CoV-2 Molecular Test
- Uh-Oh Labs Inc. UOL COVID-19 Test
- Visby Medical Respiratory Health Test
- 3EO Health COVID-19 Test
COVID-19 Antibody
- Access Bio, Inc. CareStart EZ COVID-19 IgM/IgG
- Access Bio, Inc. CareStart COVID-19 IgM/IgG
- Advaite, Inc. RapCov Rapid COVID-19 Test
- Assure (aka EcoTest, Fastep) COVID-19 IgG/IgM Rapid Test Device
- Diabetomics, Inc. CovAb SARS-CoV-2 Ab Test
- Hangzhou Biotest RightSign COVID-19 IgG/IgM Rapid Test Cassette
- also sold under the brand names "Premier Biotech” and “CoronaCHEK”
- InBios International SCoV-2 Detect IgG Rapid Test
- LumiraDx SARS-CoV-2 Ab Test
- Megna Health Rapid COVID-19 IgM/IgG Combo Test Kit
- Nirmidas MidaSpot COVID-19 Antibody Combo Detection Kit
- NowDiagnostics ADEXUSDx COVID-19 Test
- Salofa Oy Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette
- also sold under the brand names “Clarity COVIBLOCK” and “Sienna”
- Sugentech SGTi-flex COVID-19 IgG
Community Screening: If a Limited Service Laboratory wants to do testing at off-site Community Screening events, they must request Community Screening approval by checking the appropriate box on the Initial Application form or Add and/or Delete Test Procedures form, as relevant.
Under community screening, laboratory staff take testing equipment from the registered Limited Service Laboratory to an off-site location where testing will occur. At the end of the event, staff, equipment & records return to the registered Limited Service Laboratory location. Nothing can be left behind at the off-site testing location, otherwise a separate Limited Service Laboratory Registration will be required. Laboratories seeking approval to operate off-site community screening events must maintain a protocol describing in detail how laboratory testing will be performed.