FDA.reportPublic FDA data

Epstein Barr Virus VCA IgG ELISA

Primary DI
04048474027938
Brand
Epstein Barr Virus VCA IgG ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-2793
Catalog number
EIA-2793
Device description
The DRG Epstein Barr Virus – Viral Capsid antigen (EBV-VCA) IgG test system is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus,
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
MCDAntigen, Ebv, Capsid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCDAntigen, Ebv, CapsidMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924091000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924091000EBV-VCA IGG ELISA TEST SYSTEMZeus Scientific, Inc.1993-01-11MCD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048474027938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474027938040484740279384048474027938

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
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
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
00850054026613QMedix™Diagnostic Automation, Inc.MCD2024-05-23
00840239027931Epstein Barr Virus VCA IgG ELISADRG International IncMCD2023-08-24