Home GUDID 00630414210766 ADVIA Centaur® HBcT2 Quality Control Kit
Primary DI 00630414210766
Brand ADVIA Centaur® HBcT2 Quality Control Kit
Company SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model 10376699
Catalog number 10376699
Device description ADVIA Centaur® HBcT2
Published 2023-06-20
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 LOM Test, hepatitis b (b core, be antigen, be antibody, b core igm) SEI Qualitative and Quantitative Hepatitis B Virus Antibody assays
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology 2 SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00630414561233 Primary GS1 0 00630414210766 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 00630414561233 00630414561233 630414561233 0630414561233 00630414210766 00630414210766 630414210766 0630414210766
GMDN Terms# Term, Definition table Term Definition Hepatitis B virus core total antibody IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis B virus core antigen in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store upright, protect from light, do not freeze, and resuspend. Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 296822794 Device count 2 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 00630414964041 IMMULITE®/IMMULITE® 1000 Systems IG1 IGF-1 10381403 10381403 2020-09-24 00630414965017 IMMULITE®/IMMULITE® 1000 Systems SUBS 10385394 LSUBX 2020-09-24 00630414961125 IMMULITE® 2000 Systems CEA 10380995 L2KCE6 2016-09-24 00630414964980 IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH 10381430 LSKPTZ 2016-09-24 00630414970110 IMMULITE®/IMMULITE® 1000 Systems T4 Total T4 10381635 LKT45 2016-09-24 00630414972923 IMMULITE®2000 Systems Diluent Tube Caps 10385211 L2ZC 2020-09-24 00630414965734 IMMULITE® 2000 Systems Allergen Tube Caps 10282837 L2ATC 2020-09-24 00630414965741 IMMULITE® 2000 Systems Allergen Tubes 10282849 L2ATS2 2020-09-24 00630414973159 IMMULITE® 2000 Systems Diluent Tubes 10385210 L2ZT 2020-09-24 00630414974064 IMMULITE® 2000 Systems Microsampling Tube Caps 10385205 LSMC 2020-09-24 00630414954547 IMMULITE® 2000 Systems Reaction Tubes 10385206 LRXT 2016-09-24 00630414973937 IMMULITE® 2000 Systems Microsampling Tubes 10385207 LMST 2016-09-24 00630414982403 IMMULITE® 2000 XPi Sample Nesting Cups 10374178 905288 2016-09-24 00630414982410 IMMULITE® 2000 Xpi Sample Nesting Cups 10374179 905289 2016-09-24 00630414961538 IMMULITE® 2000 Systems IGF-1 10381448 L2KGF2 2020-09-24 00630414245317 Atellica IM Anti-Thyroglobulin II (aTgII) 11201759 11201759 2026-02-04 00630414245324 Atellica IM Anti-Thyroglobulin II (aTgII) 11201761 11201761 2026-02-04 00630414245331 Atellica IM aTgII Quality Control (aTgII QC) 11201752 11201752 2026-02-04 00630414245348 Atellica IM aTgII Master Curve Material (aTgII MCM) 11201751 11201751 2026-02-04 00630414245355 ADVIA Centaur Anti-Thyroglobulin II (aTgII) 11201758 11201758 2026-02-04
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