FDA.reportPublic FDA data

ASI EB VCA IgG EIA Test

Primary DI
00816057020645
Brand
ASI EB VCA IgG EIA Test
Company
ARLINGTON SCIENTIFIC, INC.
Model
NC-880096-AG
Catalog number
NC-880096-AG
Device description
Detection of Epstein Barr Viral Capsid 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
K033915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033915000MODIFICATION TO SERAQUEST EB VCA IGGQuest Intl., Inc.2004-01-16LSE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816057020645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816057020645008160570206458160570206450816057020645

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus (EBV) 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 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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00816057021697ASI RPR Automated Control Set NC-905002.5ANC-905002.5A2023-12-19
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00816057021710ASI Evolution RPR Titration DiluentNC-5300-905ANC-5300-905A2023-12-19
00816057021796ASI RPR Card Test for SyphilisNC-900100EXNC-900100EX2023-12-19
00816057021802ASI RPR Card Test for SyphilisNC-900500EXNC-900500EX2023-12-19
00816057021826ASI Color Staph Latex TestNC-285-050NC-285-0502023-12-19
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00816057020416ASI Rubella Test NC-600030ENC-600030E2016-07-08
00816057020423ASI Rubella TestNC-600100NC-6001002016-07-08
00816057020430ASI Rubella TestNC-600100ENC-600100E2016-07-08
00816057020447ASI Rubella TestNC-600500NC-6005002016-07-08
00816057020454ASI Rubella TestNC-600500ENC-600500E2016-07-08
00816057020041ASiManager-ATNC-2400-0BTNC-2400-0BT2016-07-08
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