Home GUDID 07613336218341 Elecsys CA 19-9
Primary DI 07613336218341
Brand Elecsys CA 19-9
Company Roche Diagnostics GmbH
Model 09755608190
Catalog number 09755608190
Published 2026-06-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 07613336218341 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07613336218341 07613336218341 7613336218341
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.
Regulatory Flags# DUNS number 315028860 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 false 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 07613336171509 Elecsys Calcitonin 09005676190 09005676190 2026-06-01 07613336171516 CalSet Calcitonin 09005684190 09005684190 2026-06-01 07613336188064 Elecsys Calcitonin 09005668160 09005668160 2026-06-01 07613336217641 Elecsys Anti-TSHR 09744819190 09744819190 2026-06-01 07613336218389 Elecsys Estradiol III 09755659190 09755659190 2026-06-01 07613336235546 PreciControl HIV Gen II 09465006160 09465006160 2026-05-22 07613336234457 PreciControl Syphilis 09465022190 09465022190 2026-05-15 07613336231432 Tina-quant Antistreptolysin-O II 09537368190 09537368190 2026-05-08 07613336231449 Tina-quant Antistreptolysin-O II 09537341190 09537341190 2026-05-08 07613336154342 Elecsys Anti-HBc IgM 11820567160 11820567160 2017-09-29 07613336217832 Elecsys Testosterone II 09745963190 09745963190 2026-04-21 07613336153932 Elecsys Anti-HBc IgM 07026811160 07026811160 2018-03-19 00875197004748 cobas® HBV/HCV/HIV-1 Control Kit 1.0 06998887190 2015-12-04 07613336203606 Elecsys Anti-HBc II 09014918160 09014918160 2022-04-11 07613336203613 Elecsys Anti-HBc II 09014926160 09014926160 2022-04-11 04015630938858 Elecsys AntiHAV IgM 11820591160 11820591160 2016-09-20 04015630939855 Elecsys Anti-HAV IgM 07026773190 07026773190 2017-09-07 07613336224397 cobas ISE neo 1800 analytical unit 09687416001 09687416001 2026-04-03 20875197004766 cobas® MPX (96 tests) 06998909190 06998909190 2017-02-14 00875197004779 cobas® MPX (480 tests) 06998917190 06998917190 2017-02-14
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