Curian Shiga Toxin 760630

GUDID 00840733103308

The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simultaneous detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with cultures derived from human stool specimens to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC) infections. Test results are to be used in conjunction with the patient’s clinical symptoms and history.

MERIDIAN BIOSCIENCE, INC.

Escherichia coli antigen IVD, kit, fluorescent immunoassay
Primary Device ID00840733103308
NIH Device Record Key2fb7c908-7bbe-4d2c-bff9-7761db7a9c88
Commercial Distribution StatusIn Commercial Distribution
Brand NameCurian Shiga Toxin
Version Model Number760630
Catalog Number760630
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733103308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GMZAntigens, All Types, Escherichia Coli

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-05
Device Publish Date2023-05-26

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