Home GUDID 00842768037726 Dimension EXL LOCI Troponin I High Sensitive
Primary DI 00842768037726
Brand Dimension EXL LOCI Troponin I High Sensitive
Company Siemens Healthcare Diagnostics Inc.
Model 10471068
Catalog number 10471068
Device description LOCI High-Sensitivity Troponin I (TNIH)
Published 2019-10-16
Public version status Update
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 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 00842768037726 Primary GS1 0 00630414225203 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00842768037726 00842768037726 842768037726 0842768037726 00630414225203 00630414225203 630414225203 0630414225203
GMDN Terms# Term, Definition table Term Definition Troponin I IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen, using a chemiluminescent immunoassay method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 005088112 Device count 4 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 00630414596167 Atellica CH ASO_2 11097634 11097634 2020-09-24 00630414596259 Atellica CH PreAlb 11097617 11097617 2020-09-24 00630414596440 Atellica CH GGT 11097597 11097597 2020-09-24 00630414596174 Atellica CH hsCRP 11097633 11097633 2017-12-21 00630414596198 Atellica CH CRP_2 11097631 11097631 2017-12-27 00630414597508 Atellica CH hsCRP Calibrator 11099412 11099412 2017-12-22 00630414597515 Atellica CH CRP_2 Calibrator 11099430 11099430 2017-12-22 00630414611075 Atellica CH Crea3 11537215 11537215 2026-05-08 00630414611297 Atellica CH RCRP Cal 11537245 11537245 2024-02-02 00630414596099 Atellica CH Thc 11097503 11097503 2017-12-27 00630414510156 ADVIA® Chemistry PAMY Pancreatic Amylase Reagents 10315178 1410820 2016-09-24 00630414595641 Atellica CH PAmy 11097622 11097622 2017-12-21 00630414608273 ADVIA Centaur Tumor Marker Quality Control (TM QC) 11538186 11538186 2026-05-29 00630414622859 Atellica IM Tumor Marker Quality Control (TM QC) 11538187 11538187 2026-05-29 00630414517681 ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents 10318208 3055483 2020-09-24 00842768016912 Dimension® PBNP Calibrator 10445008 RC423A 2016-09-24 00630414498942 ADVIA® Chemistry ACET Acetaminophen Reagents 10327381 7989138 2016-09-24 00630414568768 ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents 10378760 10378760 2016-09-24 00630414653259 Atellica CH Crea3 11537567 11537567 2026-05-08 00630414618456 ADVIA CENTAUR ELF MCM SET 11208709 11208709 2023-03-15
Other Devices Sharing Product Codes# 
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