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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device anti-dna antibody (enzyme-labeled), antigen, control
Product CodeLRM
Regulation Number 866.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
EUROIMMUN US INC
  SUBSTANTIALLY EQUIVALENT 1
IMMCO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories Inc II Mar-14-2011
2 Calbiotech Inc II Mar-05-2010
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