• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device assayed external control material for microbiology nucleic acid amplification (nat) assays
Definition Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
Product CodePMN
Regulation Number 866.3920
Device Class 2


Premarket Reviews
ManufacturerDecision
Bio-Rad Laboratories
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

-
-