Product code GTI— Microbiology

DIRECTIGEN MENNINGITIS TEST KIT

Classification name: Antisera, Fluorescent, All Groups, N. Meningitidis
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Total cleared: 2
First cleared: 1984-05-02
Most recent: 1992-03-18

Market context for product code GTI

FDA has cleared 2 devices under product code GTI between 1984 and 1992, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19921 clearance
19841 clearance

Top applicants under product code GTI

Bd Becton Dickinson Vacutainer Systems Preanalytic2 clearances

Recent clearances under product code GTI

K920274 — DIRECTIGEN NEISSERIA MENINGITIDIS TESTBd Becton Dickinson Vacutainer Systems Preanalytic·1992-03-18
K841308 — DIRECTIGEN MENNINGITIS TEST KITBd Becton Dickinson Vacutainer Systems Preanalytic·1984-05-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.