FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516746533
Brand
Trinity Biotech
Company
CLARK LABORATORIES, INC.
Model
525700
Device description
Substrate Solution (TMB)
Published
2019-12-27
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
K873088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K873088000VIRGO(TM) RUBELLA IGG ELISAElectro-Nucleonics Laboratories, Inc.1987-09-09LFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516746533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516746533053915167465335391516746533

GMDN Terms#

Term, Definition table
TermDefinition
Chromogenic substrate reagent IVDA reagent or solution that gives off colour in a biochemical reaction, intended to be used in combination with other IVDs in the testing of a clinical specimen, typically using an enzyme immunoassay method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume15Milliliter

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
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
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
05391516743372Trinity Biotech232510023251002016-09-21
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
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
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
00630414971469IMMULITE® 2000 Systems RUM Rubella IgMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFX2016-09-24