FDA.reportPublic FDA data

EBV-EA IgG 120 Test Kit

Primary DI
00813545025595
Brand
EBV-EA IgG 120 Test Kit
Company
SCIMEDX CORPORATION
Model
I-EBV03G
Catalog number
I-EBV03G
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LSEEpstein-Barr Virus, Other

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSEEpstein-Barr Virus, OtherMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992587000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992587000EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEMStellar Bio Systems, Inc.1999-12-22LSE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813545025595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545025595008135450255958135450255950813545025595

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the early antigen (EA) of Epstein-Barr virus (EBV) in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002215598service@scimedx.com

Regulatory Flags#

DUNS number
155424708
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
00813545026905MeDiCa1001-481001-482020-11-04
00813545026912MeDiCa1001-961001-962020-11-04
00813545026561MeDiCa010101012020-12-01
00813545026578MeDiCa010201022020-12-01
00813545026776MeDiCa082108212020-12-01
00813545026783MeDiCa082208222020-12-01
00813545026790MeDiCa0821-M0821-M2020-12-01
00813545026806MeDiCa0822-M0822-M2020-12-01
00813545026813MeDiCa083108312020-12-01
00813545026820MeDiCa083208322020-12-01
00813545026837MeDiCa0831-M0831-M2020-12-01
00813545026844MeDiCa0832-M0832-M2020-12-01
00813545026851MeDiCa083308332020-12-01
00813545026868MeDiCa0833-M0833-M2020-12-01
00813545026875MeDiCa083408342020-12-01
00813545026882MeDiCa0834-M0834-M2020-12-01
00813545026899MeDiCa0842-RM0842-M2020-12-01
00813545027223MeDiCa8021-488021-482020-12-01
00813545027261MeDiCa8021-4008021-4002020-12-01
00813545027278MeDiCa8021-96-GI8021-96-GI2020-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474027945Epstein Barr Virus VCA IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSE2023-08-29
04048474027969EBV-EA IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSE2023-08-29
00840239027948Epstein Barr Virus VCA IgM ELISADRG International IncLSE2023-08-24
00840239027962EBV-EA IgG ELISADRG International IncLSE2023-08-24
00847865011167Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LSE2023-01-22
03610522051243Bio-RadBio-RAD Laboratories, Inc.LSE2023-01-21
00847865010788Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LSE2023-01-04
00847865010795Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LSE2023-01-04
B3507206000Gold Standard Diagnostics Is-EBV-VCA IgG Test KitGold Standard Diagnostics CorporationLSE2022-12-07
B3507206100Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit Gold Standard Diagnostics CorporationLSE2022-12-07
B3507206500Gold Standard Diagnostics Is-EBV-EA-D IgM Test KitGold Standard Diagnostics CorporationLSE2022-12-07
00840733103247MERIFLUOR EBV-EA IgG IFAMERIDIAN BIOSCIENCE, INC.LSE2020-12-09
B3507206300Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test KitGold Standard Diagnostics CorporationLSE2020-07-27
05391516746564Bio-Rad PlateliaCLARK LABORATORIES, INC.LSE2019-11-14
05391516746540Bio-Rad PlateliaCLARK LABORATORIES, INC.LSE2019-11-07
05391516743365Trinity BiotechCLARK LABORATORIES, INC.LSE2019-11-05
05391516746953Trinity BiotechCLARK LABORATORIES, INC.LSE2019-11-05
05391516743334Trinity BiotechCLARK LABORATORIES, INC.LSE2019-10-25
05391516743556Trinity BiotechCLARK LABORATORIES, INC.LSE2019-10-25
05391516746946Trinity BiotechCLARK LABORATORIES, INC.LSE2019-10-25
05391516747080Trinity BiotechCLARK LABORATORIES, INC.LSE2019-10-25
05391516747196PlateliaCLARK LABORATORIES, INC.LSE2019-08-06
00817273020327DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00817273020334DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00817273020341DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00817273020365DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00813545025618EBV EA 10 Well; 10 pk SCIMEDX CORPORATIONLSE2016-09-20
00847865000161BioPlex 2200BIO-RAD LABORATORIES, INC.LSE2016-09-12
00847865002127BioPlex 2200BIO-RAD LABORATORIES, INC.LSE2016-09-12
00847865002226BioPlex 2200BIO-RAD LABORATORIES, INC.LSE2016-09-12