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 multi-analyte respiratory virus antigen detection test
Definition A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.
Product CodeSCA
Regulation Number 866.3987
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCESS BIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
HEALGEN
  GRANTED 1
IHEALTH LABS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NANO-DITECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OSANG, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRINCETON BIOMEDITECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
WONDFO USA CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2025 4 4
2026 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 23 23
Unable to Obtain Readings 17 17
False Positive Result 2 2
Imprecise or Erratic Results 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 44 44
No Clinical Signs, Symptoms or Conditions 1 1

-
-