FDA.reportPublic FDA data

QMedix™

Primary DI
00850054026484
Brand
QMedix™
Company
Diagnostic Automation, Inc.
Model
DACD3149-15
Catalog number
3149-15
Device description
QMedix™T4 ELISA kit is intended to be used to quantitatively measure total thyroxine (TT4) in a clinical specimen, using an enzyme immunoassay (EIA) method.
Published
2024-01-31
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
CDXRadioimmunoassay, Total Thyroxine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDXRadioimmunoassay, Total ThyroxineClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850054026484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054026484008500540264848500540264840850054026484

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

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
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
04048474045680T-4 Total ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDX2023-08-31
00840239045591Mycoplasma hominis IgG ELISADRG International IncCDX2023-08-25
00840239045683T-4 Total ELISADRG International IncCDX2023-08-25
06925912718512iFlash-T4Shenzhen YHLO Biotech Co., Ltd.CDX2022-10-26
07613336171660Elecsys T4Roche Diagnostics GmbHCDX2021-08-13
07613336171677Elecsys T4Roche Diagnostics GmbHCDX2021-08-13
00816870021218N-T4 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870021225N-T4 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
00816870021232N-T4 AccuBind ELISA Test System - 480 WellsMONOBIND, INC.CDX2019-02-11
00816870021249N-T4 AccuBind ELISA Test System - 960 WellsMONOBIND, INC.CDX2019-02-11
00816870021256N-T4 AccuBind ELISA Test System - 1920 WellsMONOBIND, INC.CDX2019-02-11
00816870021652T4 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870021669T4 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
00816870021676T4 AccuBind ELISA Test System - 480 WellsMONOBIND, INC.CDX2019-02-11
00816870021683T4 AccuBind ELISA Test System - 960 WellsMONOBIND, INC.CDX2019-02-11
00816870021690T4 SBS AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870021706T4 SBS AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
00816870023090T4 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870023106Monobind AccuLite T4 CLIA Kit - 192 WellsMONOBIND, INC.CDX2019-02-11
00816870023113T4 AccuLite CLIA Test System - 480 WellsMONOBIND, INC.CDX2019-02-11
00816870023120T4 AccuLite CLIA Test System - 960 WellsMONOBIND, INC.CDX2019-02-11
00816870023137T4 SBS AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870023144T4 SBS AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
00630414599984Atellica IM T4Siemens Healthcare Diagnostics Inc.CDX2018-02-06
00630414599991Atellica IM T4 DILSiemens Healthcare Diagnostics Inc.CDX2018-02-06
04015630939800Elecsys T4Roche Diagnostics GmbHCDX2017-04-21
00817830022467Total T4 MAb 125I RIA KitMP BIOMEDICALS, LLCCDX2016-10-20
00817830022474Total T4 MAb 125I RIA KitMP BIOMEDICALS, LLCCDX2016-10-20
00817830022481Total T4 MAb 125I RIA KitMP BIOMEDICALS, LLCCDX2016-10-20
00630414125121ADVIA Centaur® T4 DILSiemens Healthcare Diagnostics Inc.CDX2016-09-24