FDA.reportPublic FDA data

MERIFLUOR EBV VCA IgG IFA

Primary DI
00840733101939
Brand
MERIFLUOR EBV VCA IgG IFA
Company
MERIDIAN BIOSCIENCE, INC.
Model
EB100
Catalog number
EB100
Device description
An immunofluorescence test for the detection of EBV VCA IgG Antibodies to Epstein-Barr Virus.
Published
2020-09-21
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
GNPAntiserum, Cf, Epstein-Barr Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNPAntiserum, Cf, Epstein-Barr VirusMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K771062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K771062000EBV TESTGull Laboratories, Inc.1977-07-14GNP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101939008407331019398407331019390840733101939

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus (EBV) 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 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.

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
5132713700info@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
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
00840733101595StatID PRO COVID/Flu A&B Swabs7831107831102026-05-14
00840733101557statID Pro COVID-19/Flu External Controls7830102026-04-10
00840733101564statID Pro COVID-19/Flu A&B7830252026-04-10
00840733101717PREMIER CAMPY6180966180962020-09-01
00840733101397Fungal Immunodiffusion Plates - 4 Series1010091010092019-11-21
00840733101403Fungal Immunodiffusion Plates - 1 Series1010121010122019-11-21
00840733101014ANA Screen ELISA Test Kit488426148842612016-09-23
00840733102585Hemo-De8013008013002020-12-09
00840733102660Modified Hemo-De8016008016002020-09-21
00840733102318Revogene6102106102102020-07-15
00840733102547EcoStain8014008014002020-12-09
00840733102394SpinCon9722009722002020-10-26
00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
00840733102714Para-Pak C&S9006129006122020-12-09
00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B3507206200Gold Standard Diagnostics Is-EBNA-1 IgG ELISA Test KitGold Standard Diagnostics CorporationGNP2022-12-07
B3507206400Gold Standard Diagnostics Is-EBV-EA-D IgG Test Kit Gold Standard Diagnostics CorporationGNP2022-12-07
05391516746557Bio-Rad PlateliaCLARK LABORATORIES, INC.GNP2019-11-07
05391516747073Trinity BiotechCLARK LABORATORIES, INC.GNP2019-10-25
00817273020358DiamedixDIAMEDIX CORPORATIONGNP2016-09-20