Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

OJN · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: OJN
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: MI
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown