FDA.reportPublic FDA data

T3-Uptake ELISA

Primary DI
04048474032673
Brand
T3-Uptake ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-3267
Catalog number
EIA-3267
Device description
The measurement of the total amount of binding sites available for the Thyroid Hormones in human serum or plasma by a microplate enzyme Immunoassay.
Published
2023-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHQRadioassay, Triiodothyronine Uptake

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHQRadioassay, Triiodothyronine UptakeClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048474032673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474032673040484740326734048474032673

GMDN Terms#

Term, Definition table
TermDefinition
Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple thyroid markers associated with thyroid disease in a clinical specimen using an enzyme immunoassay (EIA) method. Analytes detected may include, but are not limited to, free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH) and/or thyroid peroxidase (TPO).

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
973-564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10758750033843VITROSORTHO CLINICAL DIAGNOSTICSKHQ2023-03-28
06925912718482iFlash-FT3Shenzhen YHLO Biotech Co., Ltd.KHQ2022-10-26
14560189212135ST AIA-PACK T-UTOSOH CORPORATIONKHQ2019-07-25
04560189212121AIA-PACK T-U CALIBRATOR SETTOSOH CORPORATIONKHQ2019-07-25
14560189212128AIA-PACK T-U CALIBRATOR SETTOSOH CORPORATIONKHQ2019-07-25
24560189212132ST AIA-PACK T-UTOSOH CORPORATIONKHQ2019-07-25
00840239032676T3-Uptake ELISADRG International IncKHQ2019-03-20
00816870021591T3 Uptake AccuBind ELISA Test System - 96 WellsMONOBIND, INC.KHQ2019-02-11
00816870021607T3 Uptake AccuBind ELISA Test System - 192 WellsMONOBIND, INC.KHQ2019-02-11
00816870023038T3 Uptake AccuLite CLIA Test System - 96 WellsMONOBIND, INC.KHQ2019-02-11
00816870023045T3 Uptake AccuLite CLIA Test System - 192 WellsMONOBIND, INC.KHQ2019-02-11
00380740131548AlinityAbbott Ireland DiagnosticsKHQ2018-10-22
00630414600246Atellica IM TupSiemens Healthcare Diagnostics Inc.KHQ2018-02-06
00630414600253Atellica IM TupSiemens Healthcare Diagnostics Inc.KHQ2018-02-06
04015630940530Elecsys T-UptakeRoche Diagnostics GmbHKHQ2017-04-14
00817830022566T3 Uptake 125I RIA 200 Tube KitMP BIOMEDICALS, LLCKHQ2017-01-09
00817830022429T3 Uptake 125I RIA KitMP BIOMEDICALS, LLCKHQ2016-10-20
00884883003453DRI T-Uptake Microgenics CorporationKHQ2016-10-03
00842768005695Dimension® Flex® reagent cartridge TUSiemens Healthcare Diagnostics Inc.KHQ2016-09-24
00842768015496Dimension Vista® Flex® reagent cartridge TUSiemens Healthcare Diagnostics Inc.KHQ2016-09-24
00884883005556DRI T-Uptake Calibrator KitMicrogenics CorporationKHQ2016-09-24
00630414177120ADVIA Centaur® TupSiemens Healthcare Diagnostics Inc.KHQ2016-09-24
00630414177137ADVIA Centaur® TupSiemens Healthcare Diagnostics Inc.KHQ2016-09-24
04015630899579Elecsys Tuptake AssayRoche Diagnostics GmbHKHQ2016-09-20
04015630916030TUptakeRoche Diagnostics GmbHKHQ2016-09-20
00884883005662CEDIA T Uptake Microgenics CorporationKHQ2016-09-12
10758750009145VITROSORTHO CLINICAL DIAGNOSTICSKHQ2016-08-26
00380740003517ARCHITECTABBOTT LABORATORIESKHQ2016-06-06
00380740042523ARCHITECTABBOTT LABORATORIESKHQ2016-06-06