inforMED
PMNClass II

Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays

Microbiology · 21 CFR 866.3920

Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.

MDR events1All time
Recalls4All time
Registered firms32Currently listed
510(k) clearances32All time

Recent MDR events

1 adverse event reports on file

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Event type breakdown

Malfunction1

Most-reported manufacturers

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Microbiologics Inc.1

Recalls

4 recall events for this product code

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Registered firms

32 firms currently registered for this product code

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510(k) clearances

32 clearances for this product code

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