Ivd Research, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
5
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K081064GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LFJanuary 14, 2009
K032897C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96May 27, 2004
K031059IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96July 10, 2003
K024113IVD CRYPTO/GIARDIA DFAMarch 5, 2003
K020583IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96September 17, 2002