FDA.reportPublic FDA data

ASI EBNA IgG EIA Test

Primary DI
00816057020638
Brand
ASI EBNA IgG EIA Test
Company
ARLINGTON SCIENTIFIC, INC.
Model
NC-870096-AG
Catalog number
NC-870096-AG
Device description
Detection of Epstein Barr Nuclear Antigen
Published
2016-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K991975000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991975000SERAQUEST EB NA IGGQuest Intl., Inc.1999-11-02LSE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816057020638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816057020638008160570206388160570206380816057020638

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) 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 G (IgG) antibodies to the Epstein-Barr virus nuclear antigen (EBNA) of 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
801-489-8911info@arlingtonscientific.com

Regulatory Flags#

DUNS number
785966607
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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