Ortho Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices

Cleared May 13, 1988

ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.

K872541 · LJN

Microbiology · 319d

Cleared Apr 27, 1988

ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST

K881500 · LJP

Microbiology · 16d

Cleared Dec 21, 1987

GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST

K872628 · LSL

Microbiology · 168d

Cleared Nov 05, 1986

ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT

K863490 · LJC

Microbiology · 57d

Cleared Feb 04, 1986

ORTHO HSV ANTIGEN ELISA TEST

K854488 · GQN

Microbiology · 88d

Cleared Dec 06, 1985

ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST

K853738 · LJP

Microbiology · 91d

Cleared Sep 12, 1985

ORTHO DNA PROBE HSV CONFIRMATION TEST

K852360 · GQL

Microbiology · 100d

Cleared Aug 28, 1985

ORTHO VIRAL TRANSPORT

K853500 · JSM

Microbiology · 8d

Cleared Jan 29, 1985

CULTURESET HSV ISOLATION & ID SYS

K842216 · GQL

Microbiology · 239d

Cleared Oct 05, 1984

ORTHO* RSV ANTIGEN ELISA TEST SYS

K842047 · LKT

Microbiology · 137d

Cleared Aug 12, 1984

ORTHO RESPIRATORY SYNCYTIAL VIRUS-

K841527 · LKT

Microbiology · 122d

Cleared Jun 25, 1984

ORTHO VARICELLA-ZOSTER VIRUS IDENT.

K841526 · GQX

Microbiology · 74d

Cleared May 21, 1984

RUBELLA IGG ANTIBODY ELISA TEST SYS

K841200 · LFX

Microbiology · 61d

Cleared May 02, 1984

HSV ANTIGEN ELISA KIT

K834449 · LGC

Microbiology · 135d

Cleared Mar 17, 1983

ORTHO RUBELLA ELISA TEST SYSTEM

K822342 · LFX

Microbiology · 225d