FDA.reportPublic FDA data

QMedix™

Primary DI
00850049545983
Brand
QMedix™
Company
Diagnostic Automation, Inc.
Model
DACD3149-18
Catalog number
3149-18
Device description
QMedix™T4 ELISA KitThis test is intended to quantitatively detect total thyroxine (T4) associated with thyroid disease in a clinical specimen using an enzyme immunoassay (EIA) method.
Published
2024-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850049545983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049545983008500495459838500495459830850049545983

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8185913030Onestep@rapidtest.com

Regulatory Flags#

DUNS number
878252071
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
00850054026446AccuDiag™ T3 ELISA KitDACD3144-153144-152026-03-02
00850082766024AccuDiag™ Mycoplasma pneumoniae IgG ELISADACD8042-28042-22026-03-02
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA DACD2506-22506-22026-02-27
00850049545433AccuDiag™ Prolactin (PRL) ELISADACD4226-154226-152026-01-30
00850054026712AccuDiag™ LH ELISADACD4225-154225-152026-01-30
00894175000800AccuDiag™ Progesterone ELISADACD2077-152077-152026-01-30
00850054026569QMedix™DACD5102-25102-22024-04-23
00850049545723AccuDiag™ Insulin ELISADACD1606-151606-152026-01-27
00850049545815AccuDiag™ Human Growth Hormone (HGH) ELISADACD1901-151901-152026-01-27
00850054026255AccuDiag™ C-Peptide ELISA KitDACD1293-151293-152026-01-27
00850054026682AccuDiag™ Estradiol ELISA DACD2046-152046-152026-01-27
00850054026705 AccuDiag™ FSH ELISADACD4224-154224-152026-01-27
00850082766017AccuDiag™ Free Estriol ELISA DACD3171-153171-152026-01-27
00894175000770AccuDiag™ 17-alpha-OH Progesterone ELISADACD1292-151292-152026-01-27
00894175000824AccuDiag™ ANST (Androstenedione) ELISADACD1038-151038-152026-01-27
10850049545492QMedix™DACD104110-1-19104110-1-192025-12-24
10850082766007QMedix™DACD113030-1-19113030-1-192025-12-24
00850049545501Diagnostic Automation, Inc.DAI SF2100SF21002025-12-24
00850054026392Diagnostic Automation, Inc.DAI SF2600SF26002025-12-24
00850049545495QMedix™DACD104110-1-19104110-1-192025-12-24

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
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
04015630916016Total T4 Thyroxine)Roche Diagnostics GmbHKLI2016-09-20