What does this mean? Anyone with any knowledge of FDA aprovals?25 Mar 2021 16:05
Looks same as that of NCYT..
Establishment:
GENEDRIVE DIAGNOSTICS LTD
48 Grafton St
Manchester Manchester, GB M13 9XX
Registration Number: 3005801368
FEI Number*: 3005801368
Status: Active
Date Of Registration Status: 2021
Owner/Operator:
Genedrive Diagnostics Ltd
48 Grafton St
Manchester, Manchester GB M13 9XX
Owner/Operator Number: 10077527
Official Correspondent:
Colleen Phythian
48 Grafton St
Manchester, Manchester GB M13 9XX
Phone: 44-016-1989024-0
US Agent:
Michael Van Der Woude
Emergo Global Represenatation
2500 Bee Cave Road
Building 1,Suite 300
Austin , TX US 78746
Phone: 512 3279997 Ext
Fax: 512 3279998
Email: USagent@UL.Com
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Proprietary Name: Genedrive (R) 96 SARS-CoV-2 kit
Classification Name: COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES
Product Code: QLT
Device Class: Not Classified
Registered Establishment Name: GENEDRIVE DIAGNOSTICS LTD
Registered Establishment Number: 3005801368
Owner/Operator: Genedrive Diagnostics Ltd
Owner/Operator Number: 10077527
Establishment Operations: Manufacturer
********************************************************************************