Light Diagnostics ™ Coxsackie B Control Slide 50208

GUDID 04061841171218

Coxsackie B Control Slide

EMD Millipore Corporation

Coxsackie A/B virus antigen IVD, reagent
Primary Device ID04061841171218
NIH Device Record Key7cdb19ee-b020-4281-9b0a-28123769768f
Commercial Distribution StatusIn Commercial Distribution
Brand NameLight Diagnostics ™ Coxsackie B Control Slide
Version Model Number50208
Catalog Number50208
Company DUNS829517072
Company NameEMD Millipore Corporation
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com
Phone1 (951) 676-8080
EmailR128863@merckgroup.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104061841171218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GNMAntisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-09
Device Publish Date2022-12-01

Devices Manufactured by EMD Millipore Corporation

04053252286612 - Light Diagnostics ™ Pan-Enterovirus Control Slides2022-12-13 Pan-Enterovirus Control Slides
04053252471827 - Light Diagnostics ™ Pan-Enterovirus Reagent 2022-12-13 Pan-Enterovirus Reagent
04061841171201 - Light Diagnostics ™ Poliovirus Control Slide2022-12-13 Poliovirus Control Slide
04061841171225 - Light Diagnostics ™ Echovirus Control Slide2022-12-13 Echovirus Control Slide
04061841171478 - Light Diagnostics ™ Enterovirus70/71 Control Slide2022-12-13 Enterovirus70/71 Control Slide
04053252270239 - Light Diagnostics ™ SimulFluor® Flu A / Flu B Reagent2022-12-09 SimulFluor® Flu A / Flu B Reagent
04053252282393 - Light Diagnostics ™ Respiratory Syncytial Virus (RSV) Control Slides2022-12-09 Respiratory Syncytial Virus (RSV) Control Slides
04053252286575 - Light Diagnostics ™ Respiratory Viral Control Slides (8 Well)2022-12-09 Respiratory Viral Control Slides (8 Well)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.