GTI · Class II · 21 CFR 866.3390

FDA Product Code GTI: Antisera, Fluorescent, All Groups, N. Meningitidis

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic.

2
Total
2
Cleared
45d
Avg days
1984
Since

FDA 510(k) Cleared Antisera, Fluorescent, All Groups, N. Meningitidis Devices (Product Code GTI)

2 devices
1–2 of 2
Cleared Mar 18, 1992
DIRECTIGEN NEISSERIA MENINGITIDIS TEST
K920274
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 56d
Cleared May 02, 1984
DIRECTIGEN MENNINGITIS TEST KIT
K841308
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 33d

About Product Code GTI - Regulatory Context