FDA.reportPublic FDA data

Revogene Mock Pie

Primary DI
00840733102332
Brand
Revogene Mock Pie
Company
MERIDIAN BIOSCIENCE, 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 the 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
2020-06-29
Public version status
New
Distribution status
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733102332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733102332008407331023328407331023320840733102332

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
092815364
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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00840733102455Para-Pak Ultra SAF9802129802122020-12-09
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00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09

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