FDA.reportPublic FDA data

ZosterGent VZV Identification Reagent

Primary DI
00860002913520
Brand
ZosterGent VZV Identification Reagent
Company
VIRO RESEARCH, LLC
Model
ZG-VL-US
Catalog number
ZG-VL2-US
Device description
ZosterGent VZV Identification Reagent Test, (2) 3 mL Vials, in Ziplock Pouch
Published
2020-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQWAntigen, Cf, (Including Cf Control), Varicella-ZosterMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942743000VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENTViro Research, Inc.1994-12-15GQW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002913520PrimaryGS10
00860002913506Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002913520008600029135208600029135200860002913520
00860002913506008600029135068600029135060860002913506

GMDN Terms#

Term, Definition table
TermDefinition
Varicella-zoster virus (VZV) antigen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from varicella-zoster virus (VZV) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3Microliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
888-626-2047info@viroresearch.com

Regulatory Flags#

DUNS number
111651798
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860002913537ZosterGent VZV Identification ReagentZG-VL-USZG-VL3-US2020-10-30
00860002913544ZosterGent VZV Identification ReagentZG-VL-USZG-VL4-US2020-10-30
00860002913551ZosterGent VZV Identification ReagentZG-VL-USZG-VL5-US2020-10-30
00860002913568ZosterGent VZV Identification ReagentZG-VL-USZG-VL6-US2020-10-30
00860002913513ZosterGent VZV Identification ReagentZG-VL-USZG-VL1-US2020-10-30
00860002913506ZosterGent VZV Identification ReagentZG-VL-USZG-VL6-US2020-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G5229028001Varicella-Zoster Virus / VZV IgG IFA 96 TestHemagen Diagnostics, Inc.GQW2023-10-05
G5229028011Varicella-Zoster Virus / VZV IgG IFA Slide Only KitHemagen Diagnostics, Inc.GQW2023-10-05
00860002913537ZosterGent VZV Identification ReagentVIRO RESEARCH, LLCGQW2020-10-30
00860002913544ZosterGent VZV Identification ReagentVIRO RESEARCH, LLCGQW2020-10-30
00860002913551ZosterGent VZV Identification ReagentVIRO RESEARCH, LLCGQW2020-10-30
00860002913568ZosterGent VZV Identification ReagentVIRO RESEARCH, LLCGQW2020-10-30
00860002913513ZosterGent VZV Identification ReagentVIRO RESEARCH, LLCGQW2020-10-30
00860002913506ZosterGent VZV Identification ReagentVIRO RESEARCH, LLCGQW2020-10-30
04053252370960Light Diagnostics SimulFluor HSV/VZV ReagentEMD Millipore CorporationGQW2020-04-16
30014613330509D3DIAGNOSTIC HYBRIDS, INC.GQW2018-07-21
30014613330493D3DIAGNOSTIC HYBRIDS, INC.GQW2016-09-15
B110VZ70120Varicella Zoster Virus Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.GQW2016-09-12
B110VZG70200Varicella Zoster IgG ControlBion Enterprises, Ltd.GQW2016-09-12
B110VZM70300Varicella Zoster IgM ControlBion Enterprises, Ltd.GQW2016-09-12
B110VZN70100Varicella Zoster Negative ControlBion Enterprises, Ltd.GQW2016-09-12
04053252371745Light Diagnostics™ Simulfluor® HSV / VZV DFA EMD Millipore CorporationGQW2016-09-09