Home GUDID 00816870022758 Cortisol AccuLite CLIA Test System - 96 Wells
Primary DI 00816870022758
Brand Cortisol AccuLite CLIA Test System - 96 Wells
Company MONOBIND, INC.
Model 3675-300
Catalog number 3675-300A
Published 2019-02-11
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name CGR RADIOIMMUNOASSAY, CORTISOL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CGR Radioimmunoassay, Cortisol Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816870022758 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816870022758 00816870022758 816870022758 0816870022758
GMDN Terms# Term, Definition table Term Definition Total cortisol IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cortisol in a clinical specimen, using a chemiluminescent immunoassay method.
Device Sizes# Type, Value, Unit table Type Value Unit Width 7.75 Inch
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
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 DI Brand Model Catalog Published 00816870021096 Anti-H. Pylori IgM AccuBind ELISA Test System - 96 Wells 1525-300 1525-300A 2019-02-11 00816870021102 Anti-H. Pylori IgG AccuBind ELISA Test System - 96 Wells 1425-300 1425-300A 2019-02-11 00816870023441 PCT AccuLite CLIA Test System - 96 Wells 9275-300 9275-300A 2024-09-13 00816870023458 PCT AccuLite CLIA Test System - 192 Wells 9275-300 9275-300B 2024-09-13 00816870023465 PCT AccuBind ELISA Test System - 96 Wells 9225-300 9225-300A 2024-09-13 00816870023472 PCT AccuBind ELISA Test System - 192 Wells 9225-300 9225-300B 2024-09-13 00816870020006 NeoLumax CLIA Analyzer IN010 IN010 2024-09-13 00816870020013 LuMatic CLIA Analyzer IN008 IN008 2024-09-13 00816870020044 Immunoassay Plate Washer IN002 IN002 2024-09-13 00816870020051 NeoEldex ELISA Analyzer IN009 IN009 2024-09-13 00816870020068 PrisMatic ELISA Analyzer IN013 IN013 2024-09-13 00816870020075 Autoplex G1 ELISA Analyzer IN006 IN006 2024-09-13 00816870020082 Autoplex G2 ELISA + CLIA Analyzer IN006-2 IN006-2 2024-09-13 00816870020402 PTH Intact AccuBind ELISA Test System - 96 Wells 9025-300 9025-300A 2024-09-13 00816870021010 PAPP-A AccuBind ELISA Test System - 192 Wells 12625-300 12625-300B 2024-09-13 00816870021164 N-17-OHP AccuBind ELISA Test System - 96 Wells 5525-300 5525-300A 2024-09-13 00816870021171 N-17-OHP AccuBind ELISA Test System - 192 Wells 5525-300 5525-300B 2024-09-13 00816870021188 N-17-OHP AccuBind ELISA Test System - 480 Wells 5525-300 5525-300D 2024-09-13 00816870021195 N-17-OHP AccuBind ELISA Test System - 960 Wells 5525-300 5525-300E 2024-09-13 00816870021201 N-17-OHP AccuBind ELISA Test System - 1920 Wells 5525-300 5525-300F 2024-09-13
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850049545242 AccuDiag ™ Diagnostic Automation, Inc. CGR 2024-01-30 05060169690691 IDS Cortisol IMMUNODIAGNOSTIC SYSTEMS LIMITED CGR 2021-04-14 00816870021317 Cortisol AccuBind ELISA Test System - 96 Wells MONOBIND, INC. CGR 2019-02-11 00816870021324 Cortisol AccuBind ELISA Test System - 192 Wells MONOBIND, INC. CGR 2019-02-11 00816870022765 Monobind AccuLite Cortisol CLIA Kit - 192 Wells MONOBIND, INC. CGR 2019-02-11 00630414167404 IMMULITE 2000 Cortisol Kit Domestic 200T SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD CGR 2018-01-15 00630414167411 IMMULITE 2000 Crotisol Kit Domestic 600T SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD CGR 2018-01-15 00817830022610 Cortisol CT 500 Tube Kit MP BIOMEDICALS, LLC CGR 2017-01-09 00817830022627 Cortisol CT 1000 Tube Kit MP BIOMEDICALS, LLC CGR 2017-01-09 00817830022306 ImmuChem Cortisol Coated Tube 125I RIA Kit MP BIOMEDICALS, LLC CGR 2016-10-20 00817830022313 Corti-Cote 125I RIA Kit MP BIOMEDICALS, LLC CGR 2016-10-20 00630414953649 IMMULITE®/IMMULITE® 1000 Systems COR Cortisol Sample Diluent SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD CGR 2016-09-24 00630414961187 IMMULITE® 2000 Systems COR Cortisol SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD CGR 2016-09-24 00630414961194 IMMULITE® 2000 Systems COR Cortisol SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD CGR 2016-09-24 00630414963761 IMMULITE®/IMMULITE® 1000 Systems COR Cortisol SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD CGR 2016-09-24 15099590231118 Access Cortisol Beckman Coulter, Inc. CGR 2016-09-09 10758750008377 VITROS ORTHO CLINICAL DIAGNOSTICS CGR 2016-08-26
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