inforMED
PJEClass II

Blood/plasma Collection Device For Dna Testing

Clinical Chemistry · 21 CFR 862.1675

A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.

MDR events581All time
Recalls0All time
Registered firms30Currently listed
510(k) clearances8All time

Recent MDR events

581 adverse event reports on file

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Event type breakdown

Malfunction581

Most-reported manufacturers

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Becton, Dickinson & Co. (broken Bow)490Becton, Dickinson And Company (bd)53Becton Dickinson & Co (franklin Lakes)16Becton Dickinson12Bd (suzhou)3Becton, Dickinson & Co.3Greiner Bio-one Na Inc.2Becton Dickinson & Co (franklin Lakes)1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

30 firms currently registered for this product code

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510(k) clearances

8 clearances for this product code

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