ZosterGent VZV Identification Reagent ZG-VL6-US

GUDID 00860002913506

ZosterGent VZV Identification Reagent Test, (6) 3 mL Vials, in Ziplock Pouch

VIRO RESEARCH, LLC

Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent Varicella-zoster virus (VZV) antigen IVD, reagent
Primary Device ID00860002913506
NIH Device Record Key5ffa486e-47a9-43dd-82c5-8233641abda6
Commercial Distribution StatusIn Commercial Distribution
Brand NameZosterGent VZV Identification Reagent
Version Model NumberZG-VL-US
Catalog NumberZG-VL6-US
Company DUNS111651798
Company NameVIRO RESEARCH, LLC
Device Count6
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com
Phone888-626-2047
Emailinfo@viroresearch.com

Device Dimensions

Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Microliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Microliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Microliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Microliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Microliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Microliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Microliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Microliter

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
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
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913506 [Unit of Use]
GS100860002913520 [Primary]
GS100860002913520 [Primary]
GS100860002913520 [Primary]
GS100860002913520 [Primary]
GS100860002913520 [Primary]
GS100860002913520 [Primary]
GS100860002913520 [Primary]
GS100860002913520 [Primary]
GS100860002913537 [Primary]
GS100860002913537 [Primary]
GS100860002913537 [Primary]
GS100860002913537 [Primary]
GS100860002913537 [Primary]
GS100860002913537 [Primary]
GS100860002913537 [Primary]
GS100860002913537 [Primary]
GS100860002913544 [Primary]
GS100860002913544 [Primary]
GS100860002913544 [Primary]
GS100860002913544 [Primary]
GS100860002913544 [Primary]
GS100860002913544 [Primary]
GS100860002913544 [Primary]
GS100860002913544 [Primary]
GS100860002913551 [Primary]
GS100860002913551 [Primary]
GS100860002913551 [Primary]
GS100860002913551 [Primary]
GS100860002913551 [Primary]
GS100860002913551 [Primary]
GS100860002913551 [Primary]
GS100860002913551 [Primary]
GS100860002913568 [Primary]
GS100860002913568 [Primary]
GS100860002913568 [Primary]
GS100860002913568 [Primary]
GS100860002913568 [Primary]
GS100860002913568 [Primary]
GS100860002913568 [Primary]
GS100860002913568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [ZosterGent VZV Identification Reagent]

00860002913506ZosterGent VZV Identification Reagent Test, (6) 3 mL Vials, in Ziplock Pouch
00860002913513ZosterGent VZV Identification Reagent Test, (1) 3 ml Vial in Ziplock Pouch

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