FDA.reportPublic FDA data

MERIFLUOR EBV VCA IgG/IgM IFA

Primary DI
00840733102035
Brand
MERIFLUOR EBV VCA IgG/IgM IFA
Company
MERIDIAN BIOSCIENCE, INC.
Model
EB211
Catalog number
EB211
Device description
Slides for the detection of EBV VCA IgG/IgM.
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

Product Codes#

Code, Name table
CodeName
JRYAntiserum, Fluorescent, Epstein-Barr Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRYAntiserum, Fluorescent, Epstein-Barr VirusMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K822734000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K822734000EBV IGM TESTGull Laboratories, Inc.1982-12-09JRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733102035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733102035008407331020358407331020350840733102035

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus (EBV) antigen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from Epstein-Barr virus (EBV) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

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
00885556914090Journey IISmith & Nephew, Inc.JRY2023-11-02
00840733101946MERIFLUOR EBV VCA IgM IFAMERIDIAN BIOSCIENCE, INC.JRY2020-09-21
00813545025540EBV-VCA IgG 120 Test Kit SCIMEDX CORPORATIONJRY2016-09-20
00813545025564EBV VCA IgG 10 wl; 10 pk SCIMEDX CORPORATIONJRY2016-09-20
B110EBG1200EBV-VCA IgG Test System, 120 TestsBion Enterprises, Ltd.JRY2016-09-12