FDA.reportPublic FDA data

MERIFLUOR EBV-EA IgG IFA

Primary DI
00840733103247
Brand
MERIFLUOR EBV-EA IgG IFA
Company
MERIDIAN BIOSCIENCE, INC.
Model
EA101
Catalog number
EA101
Device description
The MERIFLUOR EBV-EA IgG IFA Test is a sensitive and rapid immunofluorescence method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human serum. When performed according to instructions, the MERIFLUOR EBV-EA IgG IFA Test detects IgG antibodies to the diffuse (D) and restricted (R) components of the EBV-EA complex. It is of value in providing supportive information for the diagnosis of EBV associated disease.
Published
2020-12-09
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
K872617000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872617000EBV-EA TESTGull Laboratories, Inc.1988-01-05LSE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733103247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733103247008407331032478407331032470840733103247

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
800-343-3858MBITechService@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
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Primary DI, Brand, Company table
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