Home GUDID 04015630002481 Roche CARDIAC TROP T Sensitive
Primary DI 04015630002481
Brand Roche CARDIAC TROP T Sensitive
Company Roche Diagnostics GmbH
Model 11621947196
Catalog number 11621947196
Published 2016-09-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name MMI IMMUNOASSAY METHOD, TROPONIN SUBUNIT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MMI Immunoassay Method, Troponin Subunit Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04015630002481 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04015630002481 04015630002481 4015630002481
GMDN Terms# Term, Definition table Term Definition Troponin I IVD, kit, rapid ICT, clinical A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of troponin I in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 315028860 Device count 1 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 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 07613336218402 Elecsys LH 09755721190 09755721190 2026-02-19 07613336236499 Elecsys BRAHMS PCT 10456299190 10456299190 2026-02-19 04015630911707 Elecsys Myoglobin STAT CalSet 11820893122 11820893122 2016-09-20 04015630918805 Cfas PUC 3121305122 03121305122 2016-09-20 04015630919932 C.f.a.s. PAC 3555941190 03555941190 2016-09-20 04015630936373 Cfas Proteins 11355279160 11355279160 2016-09-20 04015630939060 Elecsys Myoglobin Immunoassay 12178214160 12178214160 2016-09-20 04015630939114 Elecsys BRAHMS PCT 5056888200 5056888200 2016-09-20 04015630940073 Elecsys BRAHMS PCT 07301715190 07301715190 2017-04-21 07613336224281 PreciControl Rubella IgG 09966625190 09966625190 2026-01-28 07613336206737 VENTANA DP 600 slide scanner 09311360001 09311360001 2025-12-15 07613336232125 Ionify Steroids 1 09629645160 09629645160 2025-12-11 07613336232132 Ionify Steroids 2 09634444160 09634444160 2025-12-11 07613336216958 CalSet Phospho-Tau (181P) Plasma 09697896190 09697896190 2025-11-18 07613336216965 PreciControl Phospho-Tau (181P) Plasma 09697926190 09697926190 2025-11-18
Other Devices Sharing Product Codes#