Curian Analyzer 610190

GUDID 00840733101427

Curian is an Immunoassay Analyzer designed to automate incubation, results interpretation and results reporting of immunoassay diagnostic products. Curian is intended for use with Curian fluorescent immunoassay products. Curian-compatible Meridian Bioscience products are described in individual immunoassay package inserts.

MERIDIAN BIOSCIENCE, INC.

Fluorescent immunoassay analyser IVD, point-of-care, line-powered Fluorescent immunoassay analyser IVD, point-of-care Fluorescent immunoassay analyser IVD, point-of-care Fluorescent immunoassay analyser IVD, point-of-care Fluorescent immunoassay analyser IVD, point-of-care Fluorescent immunoassay analyser IVD, point-of-care Fluorescent immunoassay analyser IVD, point-of-care Fluorescent immunoassay analyser IVD, point-of-care Fluorescent immunoassay analyser IVD, point-of-care Fluorescent immunoassay analyser IVD, point-of-care Fluorescent immunoassay analyser IVD, point-of-care Fluorescent immunoassay analyser IVD, point-of-care Fluorescent immunoassay analyser IVD, point-of-care Fluorescent immunoassay analyser IVD, point-of-care Fluorescent immunoassay analyser IVD, point-of-care Fluorescent immunoassay analyser IVD, point-of-care
Primary Device ID00840733101427
NIH Device Record Keycbe97612-5aaf-4fb6-a209-c8e66243749c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCurian Analyzer
Version Model Number610190
Catalog Number610190
Company DUNS092815364
Company NameMERIDIAN BIOSCIENCE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-techservice@meridianbioscience.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYRHelicobacter Pylori

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-22
Device Publish Date2020-05-14

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