FDA.reportPublic FDA data

MOCK PIE

Primary DI
00628055344032
Brand
MOCK PIE
Company
GenePoc Inc
Model
132331
Catalog number
132331
Device description
The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogene™ instrument and GenePOC assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower then eight in a run.
Published
2017-12-29
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
00628055344032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055344032006280553440326280553440320628055344032

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-844-616-1544fran@mdcassoc.com

Regulatory Flags#

DUNS number
202672846
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628055344001revogene™1308401308402017-12-29
00628055344070GenePOC™ Carba1334991334992019-05-24
00628055344087GenePOC™ Strep A1336741336742019-04-30
00628055344018GenePOC™ GBS LB1309321309322017-12-29
00628055344025GenePOC™ CDiff 1329941329942017-12-29

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