MOCK PIE 132331

GUDID 00628055344032

Centrifuge tube counterbalance

Primary Device ID	00628055344032
NIH Device Record Key	e010adfd-9e6d-438e-8450-6c720d70c4c8
Commercial Distribution Status	In Commercial Distribution
Brand Name	MOCK PIE
Version Model Number	132331
Catalog Number	132331
Company DUNS	202672846
Company Name	GenePoc Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00628055344032 [Primary]

OOI	Real Time Nucleic Acid Amplification System

Steralize Prior To Use	false
Device Is Sterile	false

00628055344070 - GenePOC™ Carba	2019-06-03 The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the
00628055344087 - GenePOC™ Strep A	2019-05-08 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 LB	2018-07-06 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 PIE	2018-07-06The 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 PIE	2018-07-06 The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogene™ instrument and GenePOC assays. The MOCK PIE