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Clear Health Pass

COVID-19, Influenza A & B Combo At-Home Saliva Collection Kit

The Saliva Collections Kit has been registered/authorized for Specimen Collection and Lab Transport under 21 CFR Parts §§ 862.1 – 862.9. CLIA Lab Testing of the Collected Sample has not been FDA-cleared or approved but has been authorized by the FDA under an Emergency Use Authorization (EUA202953). This product has been authorized only for detecting proteins from SARS-CoV-2, Influenza A & B, not for any other viruses or pathogens. Testing has been modified since authorization by FDA for Saliva, and the modified test has not been reviewed by FDA. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19, Influenza A & Influenza B under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C § 360bbb-3(b)(1) unless the declaration is terminated, or authorization is revoked sooner.

Clear Health Pass® Will Offer The Newest, Easiest, Most Efficient, And Most Affordable Way To Test For COVID-19. With A Simple Saliva Collection Method, It Provides A More Comfortable And User-Friendly Testing Experience For Everyone, Especially Children.**

Lab results in 24-Hours of receipt

Saliva Collection Method: Less Invasive, more comfortable, reduces the risk of transmission to the test administrator 

Telehealth Registration: Get Notified when your test results are in.

Made in the USA:  Manufactured in the USA

CONTENTS – 1 Test Per Kit

Saliva Collection Device: 1 EA | 1 Set of Gloves: 1 EA |  Face Mask : 1 EA |  
 
1 EA Biohazard Bag with absorbent sheet: 1 EA | Instructions For Use: 1 EA | Fact Sheet for Patients: 1 EA | Fact Sheet for Healthcare Providers: 1 EA | FedEx PAK with Return Shipping Label: 1 EA

Available For Purchase Now

Test Procedure

COLLECTION

Holding handle, place end of the white absorbent pad (sponge) under tongue until the “Volume Indicator” on the device changes color. This should take at least 5 minutes.

EXTRACTION

Place tube with saliva sample. Be sure that saliva volume is at or above fill line. If not, spit directly into tube. 

Next Steps: Send into lab

Place the sample tube in the included biohazard bag

Place the sample in labeled FedEx PAK

Our lab will upload results within 24-48 hours while maintaining HIPAA Compliance Standards.

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Clear Health Pass ® Is A Portfolio Partner Of The Native American Venture Fund  (NAVF). Clear Health Pass Holdings, LLC, DBA Clear Health Pass ® Is An Appointed “Tribal Agent” For The Blue Lake Rancheria Economic Development Corporation (BLREDC), A Federal, Section 17, Tribal Corporation, Whose Tribal Sovereignty Is Authority Is Derived From The Indian Reorganization Act Of 1934 (IRA), 25 U.S.C. § 477. Clear Health Pass ® Is A Minority / Veteran Operated Organization In Partnership As Tribal Representative With Federally Recognized Native American Tribes Under 25 U.S.C. §476. Clear Health Pass ® Is Doing Clinical Trials Pending Pre-Qual FDA Submittal Under Its Tribal Status. Clear Health Pass® Is Registered As Clear Health Pass Holdings, LLC And Has Filed With The US Securities And Exchange Commission Under 506c, 144 Reg D Offering.

 

*This product has not been FDA cleared or approved but has been authorized by the FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner. Bioluminescent & LAMP-CLIA Testing under IRB (21 CFR 56.106).

 

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