GSO · Class II · 21 CFR 866.3085

FDA Product Code GSO: Antigens (febrile), Agglutination, Brucella Spp.

Leading manufacturers include Sa Scientific, Inc., Lee Laboratories, Inc. and Volu Sol Medical Industries.

12
Total
12
Cleared
77d
Avg days
1979
Since

FDA 510(k) Cleared Antigens (febrile), Agglutination, Brucella Spp. Devices (Product Code GSO)

12 devices
1–12 of 12
Cleared Aug 25, 1997
VISTA ANTIGEN BRUCELLA ABORTUS
K972394
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN BRUCELLA MELITENSIS
K972396
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Jul 18, 1995
SAS BRUCELLA SUIS ANTIGEN
K952139
Sa Scientific, Inc.
Microbiology · 71d
Cleared Jul 17, 1995
SAS FEBRILE ANTIGEN SET
K952131
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS SALMONELLA H D ANTIGEN
K952135
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS SALMONELLA H B ANTIGEN
K952136
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS SALMONELLA H A ANTIGEN
K952137
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS BRUCELLA MELTIENSIS ANTIGEN
K952140
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS BRUCELLA ABORTUS ANTIGEN
K952147
Sa Scientific, Inc.
Microbiology · 70d
Cleared Aug 15, 1989
BRUCELLA IFA*
K885112
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 246d
Cleared Sep 21, 1982
FEBRILE ANTIGEN KIT
K822663
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 24, 1979
AGGLUTINOTEST-BRUCELLA
K791449
Volu Sol Medical Industries
Microbiology · 49d

About Product Code GSO - Regulatory Context