FDA.reportPublic FDA data

DRI Thyroxine (T4)

Primary DI
00884883003446
Brand
DRI Thyroxine (T4)
Company
Microgenics Corporation
Model
0454
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLIEnzyme Immunoassay, Non-Radiolabeled, Total ThyroxineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K944703000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944703000THYROXINE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.1994-12-09KLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884883003446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883003446008848830034468848830034460884883003446

GMDN Terms#

Term, Definition table
TermDefinition
Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of total thyroxine (TT4) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122153799
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884883009080MAS Immunology Advanced Sample PackICA-S12026-05-27
00884883011373MAS Immunology Advanced Level 1ICA-1012026-05-27
00884883011380MAS Immunology Advanced Level 2ICA-2022026-05-27
00884883011397MAS Immunology Advanced Level 3ICA-3032026-05-27
00884883011427CRP (C-Reactive Protein)75-54422026-05-27
00884883006751DRI Ecstasy Plus Assay100246312018-09-27
00884883001558CEDIA Heroin Metabolite (6-AM) Assay1001072016-09-26
00884883004245CEDIA Heroin Metabolite (6-AM) Assay1001082016-09-22
00884883004306CEDIA Heroin Metabolite (6-AM) Assay1001862016-09-21
00884883011366CEDIA Heroin Metabolite (6-AM) Assay100152132016-09-21
00884883009301MAS Omni•IMMUNE Max, Level 1OIMM-1012025-08-12
00884883009318MAS Omni•IMMUNE Max, Level 2OIMM-2022025-08-12
00884883009325MAS Omni•IMMUNE Max, Level 3OIMM-3032025-08-12
00884883009332MAS Omni•IMMUNE Max, Sample PackOIMM-SP2025-08-12
00884883009349MAS Omni•IMMUNE PRO Max, Level 1OPROM-1012025-08-12
00884883009356MAS Omni•IMMUNE PRO Max, Level 2OPROM-2022025-08-12
00884883009363MAS Omni•IMMUNE PRO Max, Level 3OPROM-3032025-08-12
00884883009370MAS Omni•IMMUNE PRO Max, Sample PackOPROM-SP2025-08-12
00884883009257MAS OmniCORE Max, Level 1OCRM-1012025-06-27
00884883009264MAS OmniCORE Max, Level 2OCRM-2022025-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590754488Access Total T4 IIBeckman Coulter, Inc.KLI2025-09-19
00816870023489T4 High Sensitivity AccuBind ELISA Test System - 96 wellsMONOBIND, INC.KLI2024-09-13
00816870024851T4 High Sensitivity AccuBind ELISA Test System - 192 wellsMONOBIND, INC.KLI2024-09-13
00850049545983QMedix™Diagnostic Automation, Inc.KLI2024-02-02
04048474052794Total Thyroxine (tT4) ELISADRG Instruments Gesellschaft mit beschränkter HaftungKLI2023-09-01
04048474041095Free Thyroxine (fT4) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungKLI2023-08-31
04048474017816Total Thyroxine (T4) ELISADRG Instruments Gesellschaft mit beschränkter HaftungKLI2023-08-26
00840239052797Total Thyroxine (tT4) ELISADRG International IncKLI2023-08-25
00894175000893AccuDiag ™Diagnostic Automation, Inc.KLI2023-06-14
06925912718512iFlash-T4Shenzhen YHLO Biotech Co., Ltd.KLI2022-10-26
00725609000649SPOTCHECKASTORIA-PACIFIC, INC.KLI2020-12-17
00850392007077BioCheck T4 EIA Test KitBIOCHECK, INC.KLI2019-10-08
00840239041098Free Thyroxine (fT4) ELISADRG International IncKLI2019-06-10
00840239017819Total Thyroxine (T4) ELISADRG International IncKLI2019-03-20
00380740131524AlinityABBOTT IRELANDKLI2018-12-04
00380740131517AlinityABBOTT IRELANDKLI2018-07-31
B24225TT4HUE010Total Thyroxine ELISA (Total T4 ELISA)AMERICAN LABORATORY PRODUCTS COMPANY, LTD.KLI2017-08-03
00884883005655CEDIA T4 AssayMicrogenics CorporationKLI2016-09-26
14560189210803ST AIA-PACK T4TOSOH CORPORATIONKLI2016-09-24
04560189211797AIA-PACK T4 SAMPLE DILUTING SOLUTIONTOSOH CORPORATIONKLI2016-09-24
04560189211803AIA-PACK T4 CALIBRATOR SETTOSOH CORPORATIONKLI2016-09-24
00842768005626Dimension® Flex® reagent cartridge T4Siemens Healthcare Diagnostics Inc.KLI2016-09-24
00842768015434Dimension Vista® Flex® reagent cartridge T4Siemens Healthcare Diagnostics Inc.KLI2016-09-24
00857969006273ACEALFA WASSERMANN, INC.KLI2016-09-24
00630414954370IMMULITE®/IMMULITE® 1000 Systems T4 Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00630414966038IMMULITE® 2000 Systems TT4 Total T4SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00630414966229IMMULITE®/IMMULITE® 1000 Systems T4 Total T4SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T4SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00630414972992IMMULITE® 2000 Systems TT4 Total T4SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00884883004177DRI Thyroxine (T4)Microgenics CorporationKLI2016-09-22