Ivd Research, Inc. - FDA 510(k) Cleared Devices
Recent clearances: GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF, C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL, IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ivd Research, Inc. Microbiology ✕
5 devices
Cleared
Jan 14, 2009
GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
Microbiology
275d
Cleared
May 27, 2004
C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL
Microbiology
253d
Cleared
Jul 10, 2003
IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96
Microbiology
104d
Cleared
Mar 05, 2003
IVD CRYPTO/GIARDIA DFA
Microbiology
82d
Cleared
Sep 17, 2002
IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96
Microbiology
208d