Orion Diagnostica, Inc.
FDA 510(k) medical device clearances.
Top product codes for Orion Diagnostica, Inc.
Recent clearances by Orion Diagnostica, Inc.
- K942286 — DIARLEX ROTA-ADENO
- K914892 — SALIVA-STIM
- K904655 — PYLORISET
- K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G
- K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M
- K884040 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A
- K884075 — IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN
- K864645 — ADENOLEX (R) LATEX AGGLUTINATION TEST
- K871196 — RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
- K862475 — RESPIRASTICK ENZYME IMMUNOASSAY TEST
- K854129 — ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS
- K844399 — RESPIRALEX LATEX AGGLUTINATION TEST
- K841319 — ROTALEX LATEX AGGLUTINATION TEST
- K831124 — BIOCULT - GC CULTURE-PADDLES
- K821659 — RESPIRACULT-STREP DEEP BED CULTURE PAD
- K802931 — INFLUENZA A & B S-ANTIGEN & CONTROLS
- K802930 — CYTOMEGALO VIRUS & CONTROLS
- K802929 — ADENO VIRUS & CONTROLS
- K802932 — MEASLES VIRUS & CONTROLS
- K802933 — MUMPS S & V ANTIGENS & CONTROLS
- K802934 — MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL
- K802935 — PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR
- K802936 — RESPIRATORY SYNCYTIAL VIRUS ANTIGEN &
- K802937 — RUBELLA VIRUS ANTIGENS & CONTROLS
- K802938 — VARICELLA-ZOSTER ANTIGENS & CONTROLS
- K802939 — HERPES SIMPLEX TYPE I
- K802946 — MYCOLOGY CULTURE SYSTEM
- K802947 — ORICULT DTM
Data sourced from openFDA. This site is unofficial and independent of the FDA.