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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device enzyme linked immunoabsorbent assay, rubeola igm
Definition The qualitative detection of measles specific IgM antibodies in serum or plasma.
Product CodePCL
Regulation Number 866.3520
Device Class 1


Premarket Reviews
ManufacturerDecision
TRINITY BIOTECH USA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Clark Laboratories, Inc. II Apr-27-2021
2 Clark Laboratories, Inc. (dba,Trinity Biotech USA) III Sep-12-2016
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