FDA.reportPublic FDA data

VIDAS® Varicella-Zoster IgG

Primary DI
03573026064518
Brand
VIDAS® Varicella-Zoster IgG
Company
BIOMERIEUX SA
Model
30217
Device description
VIDAS VARICEL. ZOSTER IGG assay is a qualitative IA intended for use on VIDAS family instrument in the detection of IgG antibodies to Varicella Zoster in human serum.
Published
2016-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFYEnzyme Linked Immunoabsorbent Assay, Varicella-ZosterMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923122000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923122000VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMBiomerieux Vitek, Inc.1992-10-26LFY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026064518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026064518035730260645183573026064518

GMDN Terms#

Term, Definition table
TermDefinition
Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to varicella-zoster virus (VZV) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03573026064532VIDAS® Measles IgG302192019-08-30
03573026610418VITEK®MSVITEKMS SW v1.0 / FlexPrep v1.02019-04-30
03573026644796VIDAS® Varicella-Zoster IgG30217-012026-01-19
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03573026584139ID color CatalaseID color Catalase2019-07-19
03573026092009ID color CatalaseID color Catalase2019-07-19
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03573026121631VIDAS® Quality Control307062019-11-19
B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
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03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18
03573026547509ETEST® Ceftaroline (CPT)ETEST® Ceftaroline (CPT)2016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03573026644796VIDAS® Varicella-Zoster IgGBIOMERIEUX SALFY2026-01-19
04048474028089Varicella Zoster Virus (VZV) IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLFY2023-08-29
00840239028082Varicella Zoster Virus (VZV) IgG ELISA DRG International IncLFY2023-08-24
B3507203800Gold Standard Diagnostics Is-VZV IgG ELISA Test KitGold Standard Diagnostics CorporationLFY2020-05-20
05391516746755Trinity BiotechCLARK LABORATORIES, INC.LFY2019-12-26
05391516746793Trinity BiotechCLARK LABORATORIES, INC.LFY2019-12-26
05391516746830Trinity BiotechCLARK LABORATORIES, INC.LFY2019-12-26
05391516743532Trinity BiotechCLARK LABORATORIES, INC.LFY2016-09-23
00817273020228DiamedixDIAMEDIX CORPORATIONLFY2016-09-20
00847865000727BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000734BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000741BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000758BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000765BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865002189BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865002264BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865002332BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865010757Bio-Rad Laboratories, Inc.Bio-RAD Laboratories, Inc.LFY2016-09-12
00847865010979BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00850487007012ReQuestQUEST INTERNATIONAL, INC.LFY2016-08-31
00850487007340SeraQuestQUEST INTERNATIONAL, INC.LFY2016-08-31
00816057020584ASI VZV IgG EIA TestARLINGTON SCIENTIFIC, INC.LFY2016-07-08