FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516743372
Brand
Trinity Biotech
Company
CLARK LABORATORIES, INC.
Model
2325100
Catalog number
2325100
Device description
Captia™ Toxoplasma gondii IgG
Published
2016-09-21
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
LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K871905000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K871905000TOXOPLASMA GONDII IGG ELISAElectro-Nucleonics Laboratories, Inc.1987-07-30LGD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516743372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516743372053915167433725391516743372

GMDN Terms#

Term, Definition table
TermDefinition
Toxoplasma gondii 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 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
1-800-325-3424Customerservice@trinityusa.com

Regulatory Flags#

DUNS number
623214079
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
05391516746595Immco Diagnostics517551752019-10-25
05391516743914Trinity Biotech233900023390002016-09-19
05391516742276Trinity Biotech805A805A2017-05-07
05391516743938Trinity Biotech233910023391002016-09-23
05391516746533Trinity Biotech5257002019-12-27
05391516747455Trinity Biotech43842402019-12-31
05391516743822Trinity Biotech233817023381702016-09-22
05391516743860Trinity Biotech233857023385702016-09-22
05391516747172Trinity Biotech233857123385712016-09-22
05391516747202Trinity Biotech234698023469802016-09-19
05391516747387BartelsB1029-90CB1029-90C2017-05-07
05391516747394BartelsB1029-90DB1029-90D2017-05-07
05391516746960Trinity Biotech232510123251012016-09-21
05391516746588Bio-StatYY601262019-12-30
05391516747424Phoenix BiotechTS-96-Bulk2019-12-30
05391516747493Immco230AWI2019-12-30
05391516746519Trinity Biotech8271022019-12-27
05391516746526Trinity Biotech9154012019-12-27
05391516746687Bio-Rad72517725172019-12-27
05391516746854Trinity Biotech8274022019-12-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740189976AlinityAbbott GmbHLGD2025-04-08
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
03610520150269BioPlex 2200BIO-RAD LABORATORIES, INC.LGD2017-08-05
03610521167488BioPlex 2200BIO-RAD LABORATORIES, INC.LGD2017-08-05
03610520992715BioPlex 2200BIO-RAD LABORATORIES, INC.LGD2017-08-05
04015630921485Elecsys Toxo IgMRoche Diagnostics GmbHLGD2017-07-31
04015630940318Elecsys Toxo IgMRoche Diagnostics GmbHLGD2017-07-31
04015630940301Elecsys Toxo IgGRoche Diagnostics GmbHLGD2017-04-21
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