GSZ · Class I · 21 CFR 866.3410

FDA Product Code GSZ: Antigens, Febrile (weil-felix), All Groups

Leading manufacturers include Gamma Biologicals, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Investigacion Farmaceutica S.A. DE C.V..

3
Total
3
Cleared
105d
Avg days
1976
Since

FDA 510(k) Cleared Antigens, Febrile (weil-felix), All Groups Devices (Product Code GSZ)

3 devices
1–3 of 3
Cleared Aug 15, 1989
PROTEUS OX-19 IFA*
K885110
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 246d
Cleared Nov 09, 1976
FEBRILE ANTIGEN CONTROL SERA
K760881
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 19d
Cleared Aug 03, 1976
FEBRILE ANTIGENS & CONTROL SERUMS
K760097
Gamma Biologicals, Inc.
Microbiology · 50d

About Product Code GSZ - Regulatory Context