FDA.reportPublic FDA data

T3 Uptake AccuLite CLIA Test System - 96 Wells

Primary DI
00816870023038
Brand
T3 Uptake AccuLite CLIA Test System - 96 Wells
Company
MONOBIND, INC.
Model
575-300
Catalog number
575-300A
Published
2019-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00816870023038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870023038008168700230388168700230380816870023038

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid uptake (T-uptake) IVD, kit, chemiluminescent 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 chemiluminescent immunoassay method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width7.75Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Handling Environment Temperature
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(949)951-2665info@monobind.com

Regulatory Flags#

DUNS number
083155515
Device count
1
Premarket exempt
true
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
00816870021096Anti-H. Pylori IgM AccuBind ELISA Test System - 96 Wells1525-3001525-300A2019-02-11
00816870021102Anti-H. Pylori IgG AccuBind ELISA Test System - 96 Wells1425-3001425-300A2019-02-11
00816870023441PCT AccuLite CLIA Test System - 96 Wells9275-3009275-300A2024-09-13
00816870023458PCT AccuLite CLIA Test System - 192 Wells9275-3009275-300B2024-09-13
00816870023465PCT AccuBind ELISA Test System - 96 Wells9225-3009225-300A2024-09-13
00816870023472PCT AccuBind ELISA Test System - 192 Wells9225-3009225-300B2024-09-13
00816870020006NeoLumax CLIA AnalyzerIN010IN0102024-09-13
00816870020013LuMatic CLIA AnalyzerIN008IN0082024-09-13
00816870020044Immunoassay Plate WasherIN002IN0022024-09-13
00816870020051NeoEldex ELISA AnalyzerIN009IN0092024-09-13
00816870020068PrisMatic ELISA AnalyzerIN013IN0132024-09-13
00816870020075Autoplex G1 ELISA AnalyzerIN006IN0062024-09-13
00816870020082Autoplex G2 ELISA + CLIA AnalyzerIN006-2IN006-22024-09-13
00816870020402PTH Intact AccuBind ELISA Test System - 96 Wells9025-3009025-300A2024-09-13
00816870021010PAPP-A AccuBind ELISA Test System - 192 Wells12625-30012625-300B2024-09-13
00816870021164N-17-OHP AccuBind ELISA Test System - 96 Wells5525-3005525-300A2024-09-13
00816870021171N-17-OHP AccuBind ELISA Test System - 192 Wells5525-3005525-300B2024-09-13
00816870021188N-17-OHP AccuBind ELISA Test System - 480 Wells5525-3005525-300D2024-09-13
00816870021195N-17-OHP AccuBind ELISA Test System - 960 Wells5525-3005525-300E2024-09-13
00816870021201N-17-OHP AccuBind ELISA Test System - 1920 Wells5525-3005525-300F2024-09-13

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
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