FDA.reportPublic FDA data

Epstein Barr Virus VCA IgM ELISA

Primary DI
04048474027945
Brand
Epstein Barr Virus VCA IgM ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-2794
Catalog number
EIA-2794
Device description
The DRG Epstein Barr Virus – Viral Capsid antigen (EBV-VCA) IgM test system is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human serum.
Published
2023-08-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K944449000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944449000EBV-VCA IGM ELISA TEST STSTEMZeus Scientific, Inc.1995-09-25LSE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048474027945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474027945040484740279454048474027945

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus (EBV) 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 Epstein-Barr virus (EBV) in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.

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
973-564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
Device count
1
Kit
true
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
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10
04048474035643Anti-dsDNA IgM ELISAEIA-3564EIA-35642019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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05391516747196PlateliaCLARK LABORATORIES, INC.LSE2019-08-06
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