FDA.reportPublic FDA data

DRI T-Uptake

Primary DI
00884883003453
Brand
DRI T-Uptake
Company
Microgenics Corporation
Model
0723
Published
2016-10-03
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
KHQRadioassay, Triiodothyronine Uptake

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951586000T-UPTAKE EIA TESTDiagnostic Reagents, Inc.1995-05-15KHQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884883003453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883003453008848830034538848830034530884883003453

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid uptake (T-uptake) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative determination of thyroid hormone uptake (T-uptake), or the unbound/free portion of thyroxine binding globulin (TBG) in a clinical specimen, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122153799
Device count
1
Premarket exempt
true
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
04048474032673T3-Uptake ELISA DRG Instruments Gesellschaft mit beschränkter HaftungKHQ2023-08-29
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
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