Meridian Bioscience, Inc.
FDA 510(k) medical device clearances.
Top product codes for Meridian Bioscience, Inc.
Recent clearances by Meridian Bioscience, Inc.
- K243922 — Revogene
- K230901 — Premier HpSA Flex (619096)
- K222829 — Curian® Shiga Toxin
- K222779 — Revogene
- K220480 — Revogene
- K210976 — Curian Campy
- K192817 — Curian HpSA, Curian Analyzer
- DEN180040 — Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
- K182559 — PREMIER Platinum HpSA PLUS
- K163273 — TRU Legionella
- K160829 — illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
- K153661 — ImmunoCard STAT! HpSA
- K152285 — illumigene Pertussis DNA Amplification Assay
- K152800 — illumigene Mycoplasma DNA Amplification Assay
- K151046 — illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
- K133673 — ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
- K133714 — TRU FLU
- K123423 — ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
- K122019 — STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
- K121044 — ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
- K113190 — TRU LEGIONELLA
- K112048 — IMMUNOCARD C. DIFFICILE GDH
- K112125 — ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
- K110620 — PREMIER C. DIFFICILE GDH
- K110012 — ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
- K100818 — ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
- K092553 — TRU FLU, MODEL 751230
- K090700 — IMMUNOCARD STAT CAMPY, MODEL 751530
- K083464 — PREMIER CAMPY, MODEL 618096
- K071657 — TRU FLU
- K071101 — TRU RSV
- K062546 — IMMUNOCARD STAT! EHEC, MODEL 751630
- K053335 — PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
- K041626 — IMMUNOCARD STAT! FLU A & B
- K041003 — IMMUNOCARD TOXINS A & B, MODEL 712050
- K041445 — IMMUNOCARD STAT! RSV MODEL #750630
- K032222 — IMMUNOCARDSTAT HPSA
- K023599 — IMMUNOCARD STAT! E. COLI O157 PLUS
Data sourced from openFDA. This site is unofficial and independent of the FDA.