FDA.reportPublic FDA data

Smoothelin IVD, antibody

Definition
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of smoothelin, a smooth muscle cell cytoskeleton protein, in a clinical specimen.
GUDID devices
19
Last updated
2025-03-05 15:17:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B502BSB21920Smoothelin, MMabBIO SB, INC.Concentrate, 0.1 ml 2020-02-29
B502BSB21930Smoothelin MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB21940Smoothelin MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
00810119672315Anti-SmoothelinBIOGENEX LABORATORIESAMB40-5M2023-04-05
00841683139751Smoothelin (R4A) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION377M-172022-11-14
00847627007254SmoothelinBIOCARE MEDICAL LLCCM372A2022-09-23
00847627007261SmoothelinBIOCARE MEDICAL LLCCM372C2022-09-23
00847627011732SmoothelinBIOCARE MEDICAL LLCPM372AA2022-09-23
00841683139720Smoothelin (R4A) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION377M-142020-12-14
00841683139737Smoothelin (R4A) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION377M-152020-12-14
00841683139744Smoothelin (R4A) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION377M-162020-12-14
00841683139768Smoothelin (R4A) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION377M-182020-12-07
B502BSB21890Tinto SmoothelinBIO SB, INC.Predilute, 3 ml2020-08-31
B502BSB21900Tinto Smoothelin RMabBIO SB, INC.Predilute, 7 ml 2020-08-31
B502BSB21910Tinto SmoothelinBIO SB, INC.Predilute, 15 ml 2020-08-31
00841683101215Smoothelin (R4A) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION760-45922020-08-21
L502BSB2193Smoothelin MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
L502BSB2194Smoothelin MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
L502BSB2192Smoothelin, MMabBIO SB, INC.Concentrate, 0.1 ml 2020-02-29