inforMED
QYTClass II

Over-the-counter Covid-19 Antigen Test

Microbiology · 21 CFR 866.3984

For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.

MDR events138All time
Recalls3All time
Registered firms26Currently listed
510(k) clearances14All time

Recent MDR events

138 adverse event reports on file

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Event type breakdown

Malfunction135
Injury3

Most-reported manufacturers

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Abbott Diagnostics Scarborough, Inc.103Acon Laboratories, Inc.13Azure Biotech, Inc.8Osang Llc.5Unknown2Abbott Diagnostics Scarborough, Inc.1Acon Laboratories, In1Azure Biotech Inc1

Recalls

3 recall events for this product code

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Registered firms

26 firms currently registered for this product code

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510(k) clearances

14 clearances for this product code

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