FDA.reportPublic FDA data

ASI Rubella IgG EIA Test

Primary DI
00816057020515
Brand
ASI Rubella IgG EIA Test
Company
ARLINGTON SCIENTIFIC, INC.
Model
NC-800096-AG
Catalog number
NC-800096-AG
Device description
Detection of Rubella Virus Antiboby
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
LFXEnzyme Linked Immunoabsorbent Assay, Rubella

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFXEnzyme Linked Immunoabsorbent Assay, RubellaMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961053000SERAQUEST RUBELLA IGGQuest Intl., Inc.1996-09-04LFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816057020515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816057020515008160570205158160570205150816057020515

GMDN Terms#

Term, Definition table
TermDefinition
Rubella virus 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 Rubella virus in a clinical specimen, using an enzyme immunoassay (EIA) method.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816057021666ASI EvolutionNC-2800-000NC-2800-0002023-12-19
00816057021673ASI RPR Test for Syphilis for Use on the ASI EvolutionNC-900480ABBNC-900480ABB2023-12-19
00816057021680ASI RPR Test for Syphilis for Use on the ASI EvolutionNC-9004800ABBNC-9004800ABB2023-12-19
00816057021697ASI RPR Automated Control Set NC-905002.5ANC-905002.5A2023-12-19
00816057021703ASI RPR Automated Control Set NC-905005ANC905005A2023-12-19
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
00816057021833ASI Color Staph Latex TestNC-285-050NC-285-0502023-12-19
00816057021840ASI Color Staph Latex TestNC-285-300NC-285-3002023-12-19
00816057020409ASI Rubella TestNC-600030NC-6000302016-07-08
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
00816057020058ASI Infinity AnalyzerNC-2700-000NC-2700-0002016-07-08
00816057021628ASI CRP Control SetNC-505001NC-5050012016-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740168780AlinityAbbott Ireland DiagnosticsLFX2025-12-11
07613336218440Elecsys Rubella IgMRoche Diagnostics GmbHLFX2024-10-24
00816870024165Rubella IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFX2024-09-13
00816870024172Rubella IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFX2024-09-13
00816870024202Rubella IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFX2024-09-13
00816870024219Rubella IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFX2024-09-13
00850049545686AccuDiag ™Diagnostic Automation, Inc.LFX2023-06-14
00850049545693AccuDiag ™Diagnostic Automation, Inc.LFX2023-06-14
B3507203600Gold Standard Diagnostics Is-Rubella IgG ELISA Test KitGold Standard Diagnostics CorporationLFX2020-07-27
05391516746519Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-27
05391516746526Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-27
05391516746533Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-27
05391516746878Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-27
05391516746748Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-26
05391516746786Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-26
00630414599830Atellica IM Rub MSiemens Healthcare Diagnostics Inc.LFX2018-02-06
00630414599847Atellica IM Rub M QCSiemens Healthcare Diagnostics Inc.LFX2018-02-06
00630414600529Atellica IM Rub GSiemens Healthcare Diagnostics Inc.LFX2018-02-06
00630414600536Atellica IM Rub G QCSiemens Healthcare Diagnostics Inc.LFX2018-02-06
04015630940257Elecsys Rubella IgMRoche Diagnostics GmbHLFX2017-05-10
04015630940240Elecsys Rubella IgGRoche Diagnostics GmbHLFX2017-04-21
10859035006245Alere Rubella-plus®ALERE NORTH AMERICA, LLCLFX2016-09-24
08056771100571LIAISON® Rubella IgGDIASORIN SPALFX2016-09-24
00630414201412ADVIA Centaur® Rub GSiemens Healthcare Diagnostics Inc.LFX2016-09-24
00630414201429ADVIA Centaur® Rub G QCSiemens Healthcare Diagnostics Inc.LFX2016-09-24
00630414201436ADVIA Centaur® Rub MSiemens Healthcare Diagnostics Inc.LFX2016-09-24
00630414201443ADVIA Centaur® Rub M QCSiemens Healthcare Diagnostics Inc.LFX2016-09-24
00630414962054IMMULITE® 2000 Systems RUB Rubella Quantitative IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFX2016-09-24
00630414962061IMMULITE® 2000 Systems RUB Rubella Quantitative IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFX2016-09-24
00630414964614IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFX2016-09-24