Diagnostic Hybrids, Inc. - FDA 510(k) Cleared Devices
37
Total
36
Cleared
1
Denied
33 devices
Not Cleared
May 13, 2014
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
Microbiology
81d
Cleared
Dec 23, 2009
D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
Microbiology
51d
Cleared
Dec 04, 2009
D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
Microbiology
51d
Cleared
Oct 21, 2009
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
Microbiology
33d
Cleared
Sep 11, 2009
D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
Microbiology
142d
Cleared
Aug 28, 2009
ELVIS HSV ID AND D3 TYPING TEST SYSTEM
Microbiology
73d
Cleared
Aug 28, 2009
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
Microbiology
30d
Cleared
Mar 06, 2009
D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
Microbiology
53d
Cleared
Dec 23, 2008
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
Microbiology
187d
Cleared
Dec 23, 2008
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
Microbiology
169d
Cleared
Jun 13, 2008
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
Microbiology
50d
Cleared
Oct 24, 2007
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING...
Microbiology
268d