FDA.reportPublic FDA data

Diamedix

Primary DI
00817273020327
Brand
Diamedix
Company
DIAMEDIX CORPORATION
Model
720-610
Device description
"""720-610 EBV-VCA IgM Test Kit"""
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K982352000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982352000VCA IGM ELISA TEST SYSTEMColumbia Bioscience, Inc.1998-11-25LSE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817273020327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817273020327008172730203278172730203270817273020327

GMDN Terms#

Term, Definition table
TermDefinition
Candida albicans immunoglobulin M (IgM) 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 M (IgM) antibodies to the yeast Candida albicans 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
151765328
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817273020167Diamedix720-3302016-09-20
00817273020181Diamedix720-3502016-09-20
00817273020044Diamedix300-371A2016-09-20
00817273020013Diamedix251-0352016-09-20
00817273020372Diamedix720-7002016-09-20
00817273020006Diamedix250-0302016-09-20
00817273020020Diamedix300-312A2016-09-20
00817273020037Diamedix300-331A2016-09-20
00817273020051Diamedix720-1302016-09-20
00817273020068Diamedix720-2302016-09-20
00817273020075Diamedix720-2402016-09-20
00817273020082Diamedix720-2502016-09-20
00817273020099Diamedix72-2602016-09-20
00817273020105Diamedix720-2702016-09-20
00817273020112Diamedix720-2802016-09-20
00817273020129Diamedix720-2902016-09-20
00817273020136Diamedix720-3002016-09-20
00817273020143Diamedix720-3102016-09-20
00817273020150Diamedix720-3202016-09-20
00817273020174Diamedix720-3402016-09-20

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
00817273020334DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00817273020341DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00817273020365DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00813545025595EBV-EA IgG 120 Test Kit SCIMEDX 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