FDA.reportPublic FDA data

ASI Toxoplasma IgM EIA Test

Primary DI
00816057020546
Brand
ASI Toxoplasma IgM EIA Test
Company
ARLINGTON SCIENTIFIC, INC.
Model
NC-810096-AM
Catalog number
NC-810096-AM
Device description
Detection of Toxoplasma Antibody
Published
2016-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816057020546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816057020546008160570205468160570205460816057020546

GMDN Terms#

Term, Definition table
TermDefinition
Toxoplasma gondii immunoglobulin M (IgM) 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 M (IgM) antibodies to the parasitic protozoan Toxoplasma gondii 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00816057020645ASI EB VCA IgG EIA TestNC-880096-AGNC-880096-AG2016-07-08
00816057020652ASI EB VCA IgM EIA TestNC-880096-AMNC-880096-AM2016-07-08
00816057020065ASI Staphslide TestNC-280-2-25CNC-280-2-25C2016-07-08
00816057020072ASI Staphslide TestNC-280-2-25CENC-280-2-25CE2016-07-08
00816057020089ASI Staphslide TestNC-280-2-50CNC-280-2-50C2016-07-08
00816057020096ASI Staphslide TestNC-280-2-50CENC-280-2-50CE2016-07-08
00816057020102ASI Staphslide TestNC-280-2CNC-280-2C2016-07-08
00816057020119ASI Staphslide TestNC-280-2CENC-280-2CE2016-07-08
00816057020126ASI ASO Slide TestNC-300025NC-3000252016-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00380740190002AlinityAbbott GmbHLGD2025-04-08
00380740200626AlinityAbbott GmbHLGD2025-04-08
00380740200633AlinityAbbott GmbHLGD2025-04-08
00816870024080Toxo IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LGD2024-09-13
00816870024097Toxo IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LGD2024-09-13
00816870024127Toxo IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LGD2024-09-13
00816870024134Toxo IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LGD2024-09-13
07613336218464Elecsys Toxo IgMRoche Diagnostics GmbHLGD2024-08-13
00850054026002QMedix™Diagnostic Automation, Inc.LGD2024-02-02
00850049545662AccuDiag ™Diagnostic Automation, Inc.LGD2023-06-14
B3507203000Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test KitGold Standard Diagnostics CorporationLGD2022-12-05
00380740174354AlinityAbbott GmbHLGD2022-11-26
00380740174361AlinityAbbott GmbHLGD2022-11-26
00380740203177AlinityAbbott GmbHLGD2022-11-26
05391516746823Trinity BiotechCLARK LABORATORIES, INC.LGD2019-12-26
05391516747479Trinity BiotechCLARK LABORATORIES, INC.LGD2019-12-26
00630414600123Atellica IM Toxo GSiemens Healthcare Diagnostics Inc.LGD2018-02-06
00630414600130Atellica IM Toxo G QCSiemens Healthcare Diagnostics Inc.LGD2018-02-06
00630414600147Atellica IM Toxo MSiemens Healthcare Diagnostics Inc.LGD2018-02-06
00630414600154Atellica IM Toxo M QCSiemens Healthcare Diagnostics Inc.LGD2018-02-06
03610520992715BioPlex 2200BIO-RAD LABORATORIES, INC.LGD2017-08-05
00630414208442ADVIA Centaur® Toxo MSiemens Healthcare Diagnostics Inc.LGD2016-09-24
00630414208459ADVIA Centaur® Toxo GSiemens Healthcare Diagnostics Inc.LGD2016-09-24
00630414208756ADVIA Centaur® Toxo G QCSiemens Healthcare Diagnostics Inc.LGD2016-09-24
00630414208763ADVIA Centaur® Toxo M QCSiemens Healthcare Diagnostics Inc.LGD2016-09-24
00630414962238IMMULITE® 2000 Systems TXP Toxoplasma Quantitatve IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLGD2016-09-24
00630414964805IMMULITE®/IMMULITE® 1000 Systems TXP Toxoplasma Quantitative IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLGD2016-09-24
00630414971483IMMULITE® 2000 Systems TXM Toxoplasma IgMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLGD2016-09-24
00630414976747IMMULITE® Systems TXP CONTROL Toxoplasma IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLGD2016-09-24