Home GUDID 00816870022208 Monobind AccuLite CA 19-9 CLIA Kit - 192 Wells
Primary DI 00816870022208
Brand Monobind AccuLite CA 19-9 CLIA Kit - 192 Wells
Company MONOBIND, INC.
Model 3975-300
Catalog number 3975-300B
Published 2019-02-11
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name NIG SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816870022208 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 00816870022208 00816870022208 816870022208 0816870022208
GMDN Terms# Term, Definition table Term Definition Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 19-9 (CA19-9) in a clinical specimen, using a chemiluminescent immunoassay method. CA19-9 is typically used as a marker commonly associated with gastrointestinal, pancreatic, bile duct and gallbladder cancer.
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 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 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 00816870021294 903 DBS Collection Cards - 6 Samples 329MM 329MM 2024-09-13 00816870021300 903 DBS Collection Cards - 5 Samples 621MM 621MM 2024-09-13 00816870022642 PAPP-A AccuLite CLIA Test System - 96 Wells 12675-300 12675-300A 2024-09-13 00816870022659 PAPP-A AccuLite CLIA Test System - 192 Wells 12675-300 12675-300B 2024-09-13 00816870023366 Vit D Direct AccuLite CLIA Test System - 96 wells 9475-300 9475-300A 2024-09-13 00816870023373 Vit D Direct AccuLite CLIA Test System - 192 wells 9475-300 9475-300B 2024-09-13
Other Devices Sharing Product Codes# 
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