FDA.reportPublic FDA data

uE3 AccuBind ELISA Test System - 96 Wells

Primary DI
00816870021393
Brand
uE3 AccuBind ELISA Test System - 96 Wells
Company
MONOBIND, INC.
Model
5025-300
Catalog number
5025-300A
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
CGIRADIOIMMUNOASSAY, ESTRIOL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGIRadioimmunoassay, EstriolClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870021393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870021393008168700213938168700213930816870021393

GMDN Terms#

Term, Definition table
TermDefinition
Free estriol (oestriol) IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone free estriol (oestriol) in a clinical specimen, using a radioimmunoassay method. It is typically measured in maternal blood or urine as a marker of foetal health, gestational age, or fetoplacental distress typically in pregnancies complicated by diabetes, hypertension, or prolonged gestation.

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
00850082766017AccuDiag™ Free Estriol ELISA Diagnostic Automation, Inc.CGI2026-01-27
04048474016123Free Estriol ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGI2024-11-22
04048474053517Free EstriolDRG Instruments Gesellschaft mit beschränkter HaftungCGI2023-09-01
00840239053510Free EstriolDRG International IncCGI2023-08-26
00840239016126Free Estriol ELISADRG International IncCGI2023-08-23
04049016147602Free Estriol ELISAEUROIMMUN Medizinische Labordiagnostika AGCGI2022-12-08
B261CANE6400DBC Free Estriol ELISADiagnostics Biochem Canada IncCGI2022-11-15
00404847416121Free Estriol ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGI2021-06-07
B24220FE3HUE010Free Estriol ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CGI2020-09-25
00630414984452IMMULITE®/IMMULITE® 1000 Systems UE3 Unconjugated EstriolSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGI2020-09-24
00630414997162IMMULITE® 2000 Systems UE3 Unconjugated EstriolSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGI2020-09-24
00816870021409uE3 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CGI2019-02-11
00816870022833uE3 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CGI2019-02-11
00816870022840uE3 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CGI2019-02-11
06438147355013AutoDELFIA Unconjugated Estriol (uE3) kitWallac OyCGI2018-11-16
06438147355037AutoDELFIA Unconjugated Estriol (uE3) kitWallac OyCGI2018-11-16
06438147119332AutoDELFIA Unconjugated Estriol (uE3) kitWallac OyCGI2016-06-01
06438147119745AutoDELFIA Unconjugated Estriol (uE3) kitWallac OyCGI2016-06-01