FDA.reportPublic FDA data

VIDAS® T4

Primary DI
03573026156916
Brand
VIDAS® T4
Company
BIOMERIEUX SA
Model
30404-01
Device description
The VIDAS ® T4 (T4) assay is intended for use on the VIDAS instruments for the determinat ion of human thyroxine (T4) concentration in serum or plasma (heparin).
Published
2016-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K141133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141133000VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion IIBIOMERIEUX2015-07-09LYR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026156916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026156916035730261569163573026156916

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
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
03573026064532VIDAS® Measles IgG302192019-08-30
03573026064518VIDAS® Varicella-Zoster IgG302172016-08-31
03573026610418VITEK®MSVITEKMS SW v1.0 / FlexPrep v1.02019-04-30
03573026644796VIDAS® Varicella-Zoster IgG30217-012026-01-19
03573026550523ETEST® Tigecycline (TGC)Etest® TIGECYCLINE2016-12-12
03573026584139ID color CatalaseID color Catalase2019-07-19
03573026092009ID color CatalaseID color Catalase2019-07-19
03573026559823THxID™ BRAF1.02017-05-12
03573026121631VIDAS® Quality Control307062019-11-19
B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18

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