FDA.reportPublic FDA data

ZosterGent VZV Identification Reagent

Primary DI
00860002913506
Brand
ZosterGent VZV Identification Reagent
Company
VIRO RESEARCH, LLC
Model
ZG-VL-US
Catalog number
ZG-VL6-US
Device description
ZosterGent VZV Identification Reagent Test, (6) 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
Rx
false
OTC
false
Sterile
false
Single use
false

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
00860002913537PrimaryGS10
00860002913544PrimaryGS10
00860002913551PrimaryGS10
00860002913568PrimaryGS10
00860002913506Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002913520008600029135208600029135200860002913520
00860002913537008600029135378600029135370860002913537
00860002913544008600029135448600029135440860002913544
00860002913551008600029135518600029135510860002913551
00860002913568008600029135688600029135680860002913568
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
Total Volume3Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
111651798
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860002913520ZosterGent VZV Identification ReagentZG-VL-USZG-VL2-US2020-10-30
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

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
00860002913520ZosterGent VZV Identification ReagentVIRO RESEARCH, LLCGQW2020-10-30
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
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