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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Healgen Rapid Check COVID-19 / Flu A&B Antigen Test; Healgen Rapid Check COVID-19/Flu A&B Antigen Test PRO; Healgen Rapid Check Flu A&B/COVID-19 Antigen Test; Healgen Rapid Check Flu A&B/COVID-19 Antigen Test Pro
Classification Name: MULTI-ANALYTE RESPIRATORY VIRUS ANTIGEN DETECTION TEST
Product Code: SCA
Device Class: 2
Regulation Number: 866.3987
Medical Specialty: Microbiology
Registered Establishment Name: HEALGEN SCIENTIFIC LLC
Registered Establishment Number: 3009238284
Premarket Submission Number: DEN240029
Owner/Operator: HEALGEN SCIENTIFIC LLC
Owner/Operator Number: 10038461
Establishment Operations: Manufacturer; Specification Developer; Complaint File Establishment
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