Orion Diagnostica, Inc. - FDA 510(k) Cleared Devices

Cleared Dec 14, 1994

DIARLEX ROTA-ADENO

K942286 · LIQ

Microbiology · 236d

Cleared Oct 21, 1991

PYLORISET

K904655 · LYR

Microbiology · 374d

Cleared Jun 04, 1987

ADENOLEX (R) LATEX AGGLUTINATION TEST

K864645 · GOD

Microbiology · 191d

Cleared Sep 16, 1986

RESPIRASTICK ENZYME IMMUNOASSAY TEST

K862475 · GTY

Microbiology · 78d

Cleared Jan 21, 1986

ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS

K854129 · LIQ

Microbiology · 104d

Cleared Sep 14, 1984

ROTALEX LATEX AGGLUTINATION TEST

K841319 · LIQ

Microbiology · 165d

Cleared May 09, 1983

BIOCULT - GC CULTURE-PADDLES

K831124 · JTY

Microbiology · 34d

Cleared Aug 05, 1982

RESPIRACULT-STREP DEEP BED CULTURE PAD

K821659 · JSH

Microbiology · 62d

Cleared Jan 12, 1981

INFLUENZA A & B S-ANTIGEN & CONTROLS

K802931 · GNX

Microbiology · 54d

Cleared Jan 09, 1981

CYTOMEGALO VIRUS & CONTROLS

K802930 · GQH

Microbiology · 51d

Cleared Dec 31, 1980

ADENO VIRUS & CONTROLS

K802929 · GOD

Microbiology · 42d

Cleared Dec 31, 1980

MEASLES VIRUS & CONTROLS

K802932 · GRJ

Microbiology · 42d

Cleared Dec 31, 1980

MUMPS S & V ANTIGENS & CONTROLS

K802933 · GRC

Microbiology · 42d

Cleared Dec 31, 1980

MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL

K802934 · GSB

Microbiology · 42d

Cleared Dec 31, 1980

PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR

K802935 · GQS

Microbiology · 42d

Cleared Dec 31, 1980

RESPIRATORY SYNCYTIAL VIRUS ANTIGEN &

K802936 · GQG

Microbiology · 42d

Cleared Dec 31, 1980

RUBELLA VIRUS ANTIGENS & CONTROLS

K802937 · GON

Microbiology · 42d

Cleared Dec 31, 1980

VARICELLA-ZOSTER ANTIGENS & CONTROLS

K802938 · GQW

Microbiology · 42d

Cleared Dec 31, 1980

HERPES SIMPLEX TYPE I

K802939 · GON

Microbiology · 42d

Cleared Dec 22, 1980

MYCOLOGY CULTURE SYSTEM

K802946 · JSJ

Microbiology · 33d

Cleared Dec 22, 1980

ORICULT DTM

K802947 · JSI

Microbiology · 33d