revogene™ 130840

GUDID 00628055344001

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

Primary Device ID	00628055344001
NIH Device Record Key	93da11e5-9485-4eeb-9c3b-aa0412d79086
Commercial Distribution Status	In Commercial Distribution
Brand Name	revogene™
Version Model Number	130840
Catalog Number	130840
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	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
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	00628055344001 [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™	2018-07-06The revogene™ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR.
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	2018-07-06 The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogene™ instrument and GenePOC assays. The MOCK PIE

Mark Image Registration \| Serial	Company Trademark Application Date
REVOGENE 87514391 5784546 Live/Registered	Genepoc Inc. 2017-07-03