8 results
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17ms
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Sources: EU EUDAMED, US FDA
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING
FDA Enforcement
Class I
·Ongoing·Universal Meditech Inc.·February 8, 2023
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
FDA Enforcement
Class I
·Ongoing·INNOVA MEDICAL GROUP, INC.·June 16, 2021
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
FDA Enforcement
Class I
·Ongoing·North American Diagnostics·August 10, 2022
Accula SARS-CoV-2 Test, REF: COV4100
FDA Enforcement
Class I
·Ongoing·MESA BIOTECH, INC·May 18, 2022
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
FDA Enforcement
Class I
·Ongoing·Woodside Acquisitions Inc.·May 18, 2022
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
FDA Enforcement
Class I
·Ongoing·Woodside Acquisitions Inc.·May 18, 2022
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
FDA Enforcement
Class I
·Ongoing·SML Distribution, LLC·May 11, 2022
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
FDA Enforcement
Class I
·Ongoing·SD Biosensor, Inc.·March 23, 2022