FDA.reportPublic FDA data

MOCK PIE

Primary DI
00628055344131
Brand
MOCK PIE
Company
Meridian Bioscience Canada Inc
Model
610208
Catalog number
610208
Device description
The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene® instrument and Revogene® assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower than eight in a run.
Published
2019-10-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170558000revogeneGenepoc, Inc.2017-05-25OOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628055344131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055344131006280553441316280553441310628055344131

GMDN Terms#

Term, Definition table
TermDefinition
Centrifuge tube counterbalanceA device in the form of a centrifuge tube intended to balance weight across a centrifuge rotor when processing uneven numbers of tubes or tubes containing different volumes of fluid. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-343-3858MBI-TechService@meridianbioscience.com

Regulatory Flags#

DUNS number
204006360
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628055344100Revogene®6102106102102019-11-01
00628055344117Revogene® GBS LB4102004102002019-10-21
00628055344124Revogene® C. difficile4103004103002019-10-21
00628055344162Revogene® Carba C4105004105002019-10-21
00628055344179Revogene® Strep A4104004104002019-10-21

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