Extraction Free iAMP COVID-19 Detection Testing Kit (100 tests)

Description

• Extraction-free molecular COVID-19 detection kit
• 100 tests per kit. MOQ 100 kits
• Results in under 90 minutes
• FDA EUA letter – Link
• Fact Sheet for Patients- Link
• Fact Sheet for Providers – Link
• Instruction For Use – Link
• Made in the USA

 

 

 

 

Disclaimers:

• This test has not been FDA cleared or approved
• This test has been authorized by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens; and
• 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.