ImmunoCard STAT! CAMPY 751530

GUDID 00840733101373

ImmunoCard STAT! CAMPY is an immunochromatographic rapid test for the qualitative detection of specific Campylobacter antigens in human stool.

MERIDIAN BIOSCIENCE, INC.

Multiple Campylobacter species antigen IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00840733101373
NIH Device Record Key1141c273-e329-44c4-98fa-2723053e5d61
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunoCard STAT! CAMPY
Version Model Number751530
Catalog Number751530
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LQPCampylobacter Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-28
Device Publish Date2018-08-06

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