Home GUDID 00630414287201 Atellica HEMA Calibrator
Primary DI 00630414287201
Brand Atellica HEMA Calibrator
Company Siemens Healthcare Diagnostics Inc.
Model 11374312
Catalog number 11374312
Device description AT HEMA Calibrator
Published 2026-02-06
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name KRY Calibrator for platelet counting KRZ Calibrator for hemoglobin and hematocrit measurement KSA Calibrator for red-cell and white-cell counting KSX SUBSTANCE, BLOOD GROUPING OF NON-HUMAN ORIGIN FOR IN VITRO DIAGNOSTIC USE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRY Calibrator For Platelet Counting Hematology 2 KRZ Calibrator For Hemoglobin And Hematocrit Measurement Hematology 2 KSA Calibrator For Red-Cell And White-Cell Counting Hematology 2 KSX Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00630414287201 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00630414287201 00630414287201 630414287201 0630414287201
GMDN Terms# Term, Definition table Term Definition Full blood count IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count and calculation of red cell parameters and/or platelet count.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 2 Degrees Celsius 8 Degrees Celsius Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 064608573 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00630414465401 ADVIA® Chemistry CHE Cholinesterase Reagents 10329639 10329639 2020-09-24 00630414534794 ADVIA® 1800 Analyzer 10315183 10315183 2020-09-24 00630414000510 VERSANT HCV Control 2.0 Kit (LiPA) 10719668 10719668 2017-09-15 00630414454597 ADVIA Centaur® FOL 10331250 10331250 2016-09-24 00630414482309 ADVIA® 1650 Chemistry System Ref. 10309442 10309442 2018-12-01 00630414569277 ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents 10379635 10379635 2016-09-24 00630414580722 ADVIA Centaur® aTG MCM 10492692 10492692 2016-09-24 00630414602875 VERSANT HCV 2.0 LiPA 10492004 10492004 2017-09-15 00630414602882 VERSANT HCV 2.0 LiPA 10492005 10492005 2017-09-15 00630414008950 ADVIA Chemistry P5PL_c Reagent 10729782 10729782 2021-11-04 00630414508368 ADVIA® Chemistry ALT(GPT) Reagents 10309500 10309500 2020-09-24 00630414513157 ADVIA® Chemistry IRON_2 Reagents 10341118 10341118 2020-09-24 00630414553139 ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated 10283341 10283341 2020-09-24 00630414002873 ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator 10720859 10720859 2018-07-06 00630414224923 ADVIA Cystatin C_2 Calibrator 10734510 10734510 2018-09-24 00630414517445 ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents 10341129 10341129 2016-09-24 00842768004872 Dimension® TACR Calibrator 10445012 10445012 2016-09-24 00842768018312 Dimension® Flex® reagent cartridge TACR 10444938 10444938 2016-09-24 00630414000497 VERSANT HCV 2.0 LiPA 10719666 10719666 2017-09-15 00630414000503 VERSANT HCV 2.0 LiPA 10719667 10719667 2017-09-15
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 03610230009611 ABX Minocal HORIBA ABX SAS KSA 2024-09-27 00380740151294 Alinity Abbott GmbH KRY 2023-11-16 00380740151294 Alinity Abbott GmbH KSA 2023-11-16 00380740151294 Alinity Abbott GmbH KRZ 2023-11-16 00630414224343 ADVIA® 120/2120/2120i SETpoint Siemens Healthcare Diagnostics Inc. KRZ 2016-09-24 00630414600826 ADVIA® 360/560 Calibrator Siemens Healthcare Diagnostics Inc. KRZ 2016-09-24 15099590221881 COULTER S-CAL Beckman Coulter, Inc. KRY 2016-09-23 15099590233679 COULTER S-CAL Beckman Coulter, Inc. KRY 2016-09-23 15099590233761 COULTER S-CAL Beckman Coulter, Inc. KRY 2016-09-23 04015630921096 Cfas HbA1c Roche Diagnostics GmbH KRZ 2016-09-20 20844509000246 Cal-Chex STRECK, INC. KRZ 2016-09-16 20844509000314 Cal-Chex A Plus STRECK, INC. KRZ 2016-09-16 20844509000314 Cal-Chex A Plus STRECK, INC. KSA 2016-09-16 20844509000314 Cal-Chex A Plus STRECK, INC. KRY 2016-09-16 30844509000243 Cal-Chex STRECK, INC. KRZ 2016-09-16 30844509000311 Cal-Chex A Plus STRECK, INC. KSA 2016-09-16 30844509000311 Cal-Chex A Plus STRECK, INC. KRY 2016-09-16 30844509000311 Cal-Chex A Plus STRECK, INC. KRZ 2016-09-16 40844509000318 Cal-Chex A Plus STRECK, INC. KSA 2016-09-16 40844509000318 Cal-Chex A Plus STRECK, INC. KRY 2016-09-16 40844509000318 Cal-Chex A Plus STRECK, INC. KRZ 2016-09-16 00847817000324 VARIANT II Hemoglobin A1c BIO-RAD LABORATORIES, INC. KRZ 2016-09-12 00847817011979 VARIANT II Hemoglobin A1c BIO-RAD LABORATORIES, INC. KRZ 2016-09-12 00847817013966 VARIANT II TURBO BIO-RAD LABORATORIES, INC. KRZ 2016-09-12 00847817014154 VARIANT II TURBO BIO-RAD LABORATORIES, INC. KRZ 2016-09-12 00847817014406 VARIANT II TURBO BIO-RAD LABORATORIES, INC. KRZ 2016-09-12 00847817014871 VARIANT II TURBO Link BIO-RAD LABORATORIES, INC. KRZ 2016-09-12 00380740003609 ARCHITECT ABBOTT LABORATORIES KRZ 2016-09-09 00380740003616 ARCHITECT ABBOTT LABORATORIES KRZ 2016-09-09 00380740003623 ARCHITECT ABBOTT LABORATORIES KRZ 2016-09-09
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