Home GUDID 07613336228500 Elecsys HIV Duo
Primary DI 07613336228500
Brand Elecsys HIV Duo
Company Roche Diagnostics GmbH
Model 08836973162
Catalog number 08836973162
Published 2025-02-19
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 QHM Serology tests used for infectious disease screening of blood and plasma donations
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QHM Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations Microbiology U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07613336183120 Primary GS1 0 07613336228500 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07613336183120 07613336183120 7613336183120 07613336228500 07613336228500 7613336228500
GMDN Terms# Term, Definition table Term Definition HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen, using an chemiluminescent immunoassay method.
Regulatory Flags# DUNS number 315028860 Device count 10 DM exempt false Premarket exempt false 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 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 07613336146996 cobas® Microbial Inactivation Solution 08185476001 08185476001 2026-03-26 07613336200544 cobas c 703 analytical unit 09502971001 09502971001 2026-03-20 07613336220191 cobas pro SBL c 703 09796754001 09796754001 2026-03-20 07613336222331 ISE Internal Standard Gen.2 conc. 09137742190 09137742190 2026-03-20 04015630926091 Testosterone II CalSet II 05202230190 05202230190 2026-02-23
Other Devices Sharing Product Codes#