ImmunoCard STAT E. coli O157 Plus 750530

GUDID 00840733101816

The ImmunoCard STAT E. coli O157 Plus is a rapid test for the detection of antigens from Shiga toxin-production E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, stool in modified Cary-Blair medium or confirmatory stool cultures grown in MacConkey broth of sorbitol MacConkey (SMAC) plates. In the US, ImmunoCard STAT E. coli O157 Plus is not intended for point-of-care use. This device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use.

MERIDIAN BIOSCIENCE, INC.

Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00840733101816
NIH Device Record Keyb1fa9f3d-1096-4ec3-9038-9921675cd506
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunoCard STAT E. coli O157 Plus
Version Model Number750530
Catalog Number750530
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

Customer Support Contacts

Phone5132713700
Emailinfo@meridianbioscience.com
Phone5132713700
Emailinfo@meridianbioscience.com
Phone5132713700
Emailinfo@meridianbioscience.com
Phone5132713700
Emailinfo@meridianbioscience.com
Phone5132713700
Emailinfo@meridianbioscience.com
Phone5132713700
Emailinfo@meridianbioscience.com
Phone5132713700
Emailinfo@meridianbioscience.com
Phone5132713700
Emailinfo@meridianbioscience.com
Phone5132713700
Emailinfo@meridianbioscience.com
Phone5132713700
Emailinfo@meridianbioscience.com
Phone5132713700
Emailinfo@meridianbioscience.com
Phone5132713700
Emailinfo@meridianbioscience.com
Phone5132713700
Emailinfo@meridianbioscience.com
Phone5132713700
Emailinfo@meridianbioscience.com
Phone5132713700
Emailinfo@meridianbioscience.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101816 [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 Date2020-09-29
Device Publish Date2020-09-21

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