Home GUDID 00816870020488 CA-125 AccuBind ELISA Test System - 192 Wells
Primary DI 00816870020488
Brand CA-125 AccuBind ELISA Test System - 192 Wells
Company MONOBIND, INC.
Model 3025-300
Catalog number 3025-300B
Published 2019-02-11
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name LTK TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816870020488 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 00816870020488 00816870020488 816870020488 0816870020488
GMDN Terms# Term, Definition table Term Definition Cancer antigen 125 (CA125) IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 125 (CA125), a marker commonly associated with ovarian cancer, in a clinical specimen using an enzyme immunoassay (EIA) 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 Special Storage Condition, Specify 0 0 Handling Environment Temperature 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# 
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