FDA.reportPublic FDA data

uE3 AccuLite CLIA Test System - 192 Wells

Primary DI
00816870022840
Brand
uE3 AccuLite CLIA Test System - 192 Wells
Company
MONOBIND, INC.
Model
5075-300
Catalog number
5075-300B
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
CGIRADIOIMMUNOASSAY, ESTRIOL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGIRadioimmunoassay, EstriolClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870022840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870022840008168700228408168700228400816870022840

GMDN Terms#

Term, Definition table
TermDefinition
Free estriol (oestriol) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free estriol (oestriol) in a clinical specimen, using a chemiluminescent immunoassay 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
00816870021393uE3 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CGI2019-02-11
00816870021409uE3 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CGI2019-02-11
00816870022833uE3 AccuLite CLIA Test System - 96 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