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 Registration Application (DOH-4081) [2] or adding this testing to an existing registration using the Add and/or Delete Test Procedures Form [3], you must indicate both:

1. the type of COVID-19 test (antigen, molecular, or antibody) 
2. the specific test/device 

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

• Abbott BinaxNOW COVID-19 Ag Card
• Abbott BinaxNOW COVID-19 Ag 2 Card
• Abbott BinaxNOW COVID-19 Ag Card Home Test
• Abbott BinaxNOW COVID-19 Ag Card 2 Home Test
• Abbott BinaxNOW COVID-19 Antigen Self Test
• Access Bio CareStart COVID-19 Antigen Test
• Access Bio CareStart COVID-19 Antigen Home Test
• Access Bio CareStart COVID-19 Antigen Home Test
• ACON Laboratories Flowflex COVID-19 Antigen Home Test
• ANP Technologies NIDS COVID-19 Antigen Rapid Test Kit
• Becton, Dickinson (BD) Veritor At-Home COVID-19 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
• Celltrion DiaTrust COVID-19 Ag Rapid Test
• Ellume COVID-19 Home Test
• ellume.lab COVID Antigen Test
• GenBody COVID-19 Ag
• InBios International, Inc. SCoV-2 Ag Detect Rapid Test
• Luminostics Clip COVID Rapid Antigen Test
• LumiraDx SARS-CoV-2 Ag 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 Tes
• PHASE Scientific International, Ltd. INDICAID COVID-19 Rapid Antigen Test
• Princeton BioMeditech Corp. Status COVID-19/Flu
• 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
• Xtrava Health SPERA COVID-19 Ag Test

COVID-19 Molecular

• Abbott ID NOW COVID-19
• BioFire Diagnostics Respiratory Panel 2.1 EZ
• Cepheid Xpert Omni SARS-CoV-2
• Cepheid Xpert Xpress SARS-CoV-2
• Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV
• Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV plus
• Cue Health COVID-19 Test
• Cue Health COVID-19 Test for Home and Over the counter (OTC) Use
• Detect Covid-19 Test
• Lucira CHECK-IT COVID-19 Test Kit
• Lucira COVID-19 All-In-One Test Kit
• Mesa Biotech Accula SARS-CoV-2
• Roche Molecular cobas Liat System SARS-CoV-2/Influenza A/B
• Roche Molecular cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
• Talis One COVID-19 Test System
• Visby Medical COVID-19 Point of Care 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 (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.

Complete the form below and return by mail only with $200 application fee.

Initial Limited Service Laboratory Registration Application (DOH-4081) [2]

The submission of incomplete application materials will delay the processing and the issuance of registration certificates.  Please allow a minimum of three (3) weeks to process applications from the date that they are received in our office.

Once the Limited Service Laboratory Registration application is approved, an initial registration certificate will be issued. The certificate will serve to verify your enrollment with this Program and will also provide documentation of your CLIA registration number.  Registrants may only perform the tests listed on the registration certificate issued by the Department. Certificates are valid for two years from the date issued.

MULTI-SITE REGISTRATIONS: Government owned laboratories or sites operated under the same not-for profit corporation may file for a multi-site registration. 

• To initiate a multi-site registration, please complete the Initial Limited Service Laboratory Registration Application form for the primary site and a Limited Service Laboratory Multi-Site Application form for each secondary site.
• If adding a secondary site to an existing CLIA registration number, complete Limited Service Laboratory Multi-site Application.

Limited Service Laboratory Multi-Site Application [4]

Registration certificates for all locations in the network will be sent to the Primary Site location. Multi-site network registrants may only perform the tests listed on the registration certificate issued to the Primary Site. Certificates are valid for two years from the date issued.

To document changes in Limited Service Laboratory Registration status, or to add and/or delete tests, fill out the appropriate form below. 

• Change in Laboratory Director [5]
• Change in Laboratory Owner Information [6]
• Change in Laboratory Location [7]
• Add and/or Delete Test Procedures [3]
• Change in Laboratory Name [8]

Be aware that completed change forms and any accompanying documentation may be returned BY ONE METHOD ONLY, via fax or email, with a high quality scan via email being the preferred method.  The submission of duplicate and/or incomplete paperwork will delay the processing and the issuance of amended registration certificates.  Please allow a minimum of three (3) weeks to process changes from the date that they are received in our office.

Amended registration certificates will be issued/mailed on the effective date of the change.

Test additions and deletions do not go in effect until an amended certificate has been issued demonstrating the requested change.

Once the Limited Service Laboratory Registration application is approved, an initial registration certificate will be issued.  The certificate will serve to verify your enrollment with this Program and will also provide documentation of your CLIA registration number.  If you are applying for a multi-site network registration, registration certificates for all locations in the network will be sent to the Primary Site location. Registrants may only perform the tests listed on the registration certificate issued by the Department. Multi-site network registrants may only perform the tests listed on the registration certificate issued to the Primary Site.  

Certificates are valid for two years from the date issued.  Approximately three months before a registration expires, you will be sent materials via mail to renew your Limited Service Laboratory Registration and/or Limited Service Laboratory Multi-Site Network Registration.  It is important for laboratories to keep our office informed of changes which may affect the delivery of registration materials, for example:

• Contact Person
• Laboratory Director
• Laboratory Address
• Alternate Mailing Address
• A working Email Address

If we are unable to deliver registration materials to you in a timely manner, your laboratory’s Limited Service Laboratory Registration may lapse. Be aware that reapplications must be returned by mail only (with original signatures).  The submission of incomplete and/or late reapplication materials will delay the processing and the issuance of new registration certificates

Renewal registration certificates will be mailed approximately two weeks prior to the current certificate expiration date.

The $200.00 Initial Limited Service Laboratory Registration and/or Limited Service Laboratory Registration Reapplication fees should be enclosed with your registration materials.  This fee is non-refundable.

Paying by check or money order: Make the payment out to New York State Department of Health.  Your payment should be mailed with your application and/or reapplication materials. It should include your PFI#, or the complete facility name in the memo area of the check (or check stub).

For making payments in State Financial System (SFS):

• The payment should be classified as "Outside Party", not "Interagency".
• The Vendor ID is:  0430000056
• The Vendor Name is:  DOH CLEU Revenue Account, short name is DOH CLEU R-001
• Select “2” for address to send directly to the CLEP.  This should read Clinical Lab Eval Prog Wadsworth Ctr, PO Box 509 Empire State Plz, Albany, NY 12201-0509
• For Location: enter 'Maincheck' to generate a physical check. This method will ensure that CLEP receives and applies your payment in a timely fashion.  Please do not use 'Mainepay'.
• Please include the PFI of the limited laboratory in the invoice#.  This will ensure the payment is properly applied.
• Please ensure that the information as requested above is reflected on both the Invoice Information Tab and the Payments Tab in SFS
• For an initial application, when the PFI is not known, please include the applicant name as a message in the Payment Method section on the Payments tab in SFS.

Instructions to volunteer ambulance services seeking a fee waiver: Volunteer ambulance services (as defined in Article 30 of the Public Health Law and operated under Section 209-B of the General Municipal Law) seeking a waiver of the $200.00 Initial Limited Service Laboratory Registration Application and/or Limited Service Laboratory Reapplication fees must provide copies of both of the following documents with your application and/or reapplication materials. 

• Application for EMS Operating Certificate, form DOH-206 that was filed with the Bureau of EMS
• Your current EMS Operating Certificate

This documentation may be obtained through the Bureau of EMS Central Office at 518-402-0996, or through the Bureau of EMS [9].

1. Considerations Prior to Submitting an Initial Registration Appplication [10]
2. Considerations Before, During and After Testing [11]
3. Initial Registration Application [12]
4. Multi-network Registration Application [13]
5. Considerations for Rapid HIV Testing [14]
6. Considerations for Rapid Hepatitis C Testing [15]
7. Registration Application Reapplication [16]
8. Changing a Registration Certificate [17]

Standard Practices in Laboratory Medicine for Limited Service Laboratories [18]

Centers For Disease Control Publication “Good Laboratory Practices for Waived Testing Sites [19]”      

Amendments to Article 5, Title V Public Health Law effective August 7, 2008 Subsection 579 Scope and Exceptions and Subsection 580 Construction [20]

Article 5, Title V Public Health Law effective August 7, 2008, Subsection 579 Scope and Exceptions

• Follow the link [21], enter "579" in the search box and click "Public Health Law 579"

Search FDA Database for Approved Test Devices [22]       

Search FDA Database for IVD Over-The-Counter Lab Test Devices [23]     

NYS Department of Education Office of Professions [24]                  

NYS Department of Health AIDS Institute [25]           

NYS Department of Health Blood Lead Testing Information for Laboratories [26]  

NYS Department of Health Bureau of EMS [27]          

NYS Department of Health Hepatitis C Program [28]             

Physician Office Laboratory Evaluation Program [29]  

NYS Office of Alcoholism and Substance Abuse Services [30]