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510(k) K140455

CAPTIA MEASLES IGM by Trinity Biotech USA — Product Code PCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2014
Date Received
February 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Device Class
Class I
Regulation Number
866.3520
Review Panel
MI
Submission Type

The qualitative detection of measles specific IgM antibodies in serum or plasma.

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