Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 show TPLC since Back to Search Results
Device assayed external control material for microbiology nucleic acid amplification (nat) assays
Regulation Description Assayed quality control material for clinical microbiology 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
BIOFIRE DEFENSE, LLC
  SUBSTANTIALLY EQUIVALENT 1
MAINE MOLECULAR QUALITY CONTROLS, INC.
  SUBSTANTIALLY EQUIVALENT 8
STRECK
  SUBSTANTIALLY EQUIVALENT 3
STRECK, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRECK, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZEPTOMETRIX
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1

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

-
-