FDA.reportPublic FDA data

N-TBG AccuBind ELISA Test System - 192 Wells

Primary DI
00816870021270
Brand
N-TBG AccuBind ELISA Test System - 192 Wells
Company
MONOBIND, INC.
Model
8925-300
Catalog number
8925-300B
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
CEERadioimmunoassay, thyroxine-binding globulin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEERadioimmunoassay, Thyroxine-Binding GlobulinClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870021270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870021270008168700212708168700212700816870021270

GMDN Terms#

Term, Definition table
TermDefinition
Thyroxine binding globulin (TBG) IVD, kit enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroxine binding globulin (TBG) 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
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
00816870021263N-TBG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CEE2019-02-11
00816870021287N-TBG AccuBind ELISA Test System - 480 WellsMONOBIND, INC.CEE2019-02-11
00816870021751Monobind AccuBind TBG ELISA Kit - 96 WellsMONOBIND, INC.CEE2019-02-11
00816870023199Monobind AccuLite TBG CLIA Kit - 96 WellsMONOBIND, INC.CEE2019-02-11
00630414953298IMMULITE® Systems TBG CONTROLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEE2016-09-24
00630414954271IMMULITE® 2000 Systems TGB TBG Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEE2016-09-24
00630414962078IMMULITE® 2000 Systems TBGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEE2016-09-24
00630414962207IMMULITE® 2000 Systems TU Thyroid UptakeSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEE2016-09-24
00630414964652IMMULITE®/IMMULITE® 1000 Systems TBGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEE2016-09-24
00630414978222IMMULITE®/IMMULITE® 1000 Systems TU Thyroid UptakeSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEE2016-09-24