MOCK PIE 132331

GUDID 00628055344032

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.

GenePoc Inc

Centrifuge tube counterbalance
Primary Device ID00628055344032
NIH Device Record Keye010adfd-9e6d-438e-8450-6c720d70c4c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMOCK PIE
Version Model Number132331
Catalog Number132331
Company DUNS202672846
Company NameGenePoc Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com
Phone1-844-616-1544
Emailfran@mdcassoc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100628055344032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOIReal Time Nucleic Acid Amplification System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-12-29

Devices Manufactured by GenePoc Inc

00628055344070 - GenePOC™ Carba2019-06-03 The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the
00628055344087 - GenePOC™ Strep A2019-05-08 The GenePOC Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that util
00628055344001 - revogene™2018-07-06 The revogene™ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assa
00628055344018 - GenePOC™ GBS LB2018-07-06 The GenePOC™ GBS LB assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test designed to detect
00628055344025 - GenePOC™ CDiff 2018-07-06 The GenePOC™ CDiff assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test that utilizes autom
00628055344032 - MOCK PIE2018-07-06The 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.
00628055344032 - MOCK PIE2018-07-06 The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogene™ instrument and GenePOC assays. The MOCK PIE

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