ImmunoCard H. pylori 710030

GUDID 00840733101779

The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgG to Helicobacter pylori in human serum, plasma, or whole blood. Test results are intended to aid in the diagnosis of H. pylori infection. The ImmunoCard H. pylori assay may be performed in clinical laboratories and physician's offices.

MERIDIAN BIOSCIENCE, INC.

Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00840733101779
NIH Device Record Key176af6b8-b00b-4cab-9f86-bcbd4329b117
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunoCard H. pylori
Version Model Number710030
Catalog Number710030
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

Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101779 [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 Date2020-08-19
Device Publish Date2020-08-11

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