Ortho Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
126
Total
126
Cleared
0
Denied
40 devices
Cleared
Nov 05, 1993
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
Microbiology
228d
Cleared
Jul 16, 1993
ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA
Microbiology
193d
Cleared
Jul 16, 1993
ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA
Microbiology
193d
Cleared
Dec 28, 1992
ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION
Microbiology
91d
Cleared
Aug 11, 1992
ORTHO CHLAMYDIA ANTIGEN ELISA TEST
Microbiology
148d
Cleared
Jun 22, 1992
MODIFIED ORTHO EBV VCA-IGG ELISA
Microbiology
143d
Cleared
Apr 22, 1992
ORTHO HSV ANTIGEN ELISA TEST
Microbiology
133d
Cleared
Jun 10, 1991
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST
Microbiology
63d
Cleared
Jun 10, 1991
EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST
Microbiology
63d
Cleared
Jun 10, 1991
EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST
Microbiology
63d
Cleared
Mar 19, 1991
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION
Microbiology
34d
Cleared
Dec 21, 1990
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
Microbiology
157d
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