Medical Device Manufacturer · US , Carlsbad , CA

Ivd Research, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2002

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ivd Research, Inc. Microbiology ✕

5 devices

1-5 of 5

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