PREMIER CAMPY 618096

GUDID 00840733101717

Premier CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures. Premier CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.

MERIDIAN BIOSCIENCE, INC.

Campylobacter jejuni antibody IVD, enzyme immunoassay (EIA)
Primary Device ID00840733101717
NIH Device Record Keycc3fba80-f090-4a40-b0f4-e6eec2b19f27
Commercial Distribution StatusIn Commercial Distribution
Brand NamePREMIER CAMPY
Version Model Number618096
Catalog Number618096
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101717 [Primary]

FDA Product Code

LQPCampylobacter Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-09
Device Publish Date2020-09-01

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