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 mycobacterium tuberculosis, cell mediated immune response, enzyme-linked immunospot test
Definition For the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP-10 and indicated for use as an aid in the diagnosis of M. tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.
Product CodeOJN
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
0 3 2 0 4 3

Recalls
Manufacturer Recall Class Date Posted
1 OXFORD IMMUNOTEC LTD II Aug-26-2022
2 Oxford Immunotec III Sep-16-2020
-
-