FDA.reportPublic FDA data

Tg AccuBind ELISA Test System - 192 Wells

Primary DI
00816870021775
Brand
Tg AccuBind ELISA Test System - 192 Wells
Company
MONOBIND, INC.
Model
2225-300
Catalog number
2225-300B
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
MSWSystem, test, thyroglobulin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSWSystem, Test, ThyroglobulinImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870021775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870021775008168700217758168700217750816870021775

GMDN Terms#

Term, Definition table
TermDefinition
Thyroglobulin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroglobulin in a clinical specimen, using an enzyme immunoassay (EIA) 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
00630414238418Atellica IM TgSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2025-09-22
00630414238425Atellica IM TgSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2025-09-22
15099590754501Access ThyroglobulinBeckman Coulter, Inc.MSW2023-12-01
07613336169582Elecsys Tg IIRoche Diagnostics GmbHMSW2023-10-31
07613336203569Elecsys Tg IIRoche Diagnostics GmbHMSW2023-10-31
00630414953199IMMULITE® Systems GAS CONTROL GastrinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2020-09-24
00816870021768Tg AccuBind ELISA Test System - 96 WellsMONOBIND, INC.MSW2019-02-11
00816870023205Monobind AccuLite Tg CLIA Kit - 96 WellsMONOBIND, INC.MSW2019-02-11
00816870023212Tg AccuLite CLIA Test System - 192 WellsMONOBIND, INC.MSW2019-02-11
00630414954301IMMULITE®/IMMULITE® 1000 Systems TG Thyroglobulin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414954318IMMULITE® 2000 Systems TG Thyroglobulin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414954523IMMULITE® Systems TG Recovery Sample ThyroglobulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414972077IMMULITE®/IMMULITE® 1000 Systems TG ThyroglobulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414972084IMMULITE® 2000 Systems TG ThyroglobulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
00630414978345IMMULITE® Systems TG CONTROL ThyroglobulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMSW2016-09-24
15099590225858Access Thyroglobulin Sample DiluentBeckman Coulter, Inc.MSW2016-09-09
15099590227166Access Thyroglobulin CalibratorsBeckman Coulter, Inc.MSW2016-09-09
15099590227173Access ThyroglobulinBeckman Coulter, Inc.MSW2016-09-09
04260157631106B.R.A.H.M.S Tg-pluS RIAB.R.A.H.M.S GmbHMSW2016-08-17