Home GUDID 00380740020347 CELL-DYN
Primary DI 00380740020347
Brand CELL-DYN
Company ABBOTT LABORATORIES
Model 09H70-01
Catalog number 09H7001
Device description CELL-DYN 18 PLUS CALIBRATOR
Published 2016-06-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name KRZ CALIBRATOR FOR HEMOGLOBIN AND HEMATOCRIT MEASUREMENT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRZ Calibrator For Hemoglobin And Hematocrit Measurement Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00380740020347 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 00380740020347 00380740020347 380740020347 0380740020347
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 Storage Environment Temperature 2 Degrees Celsius 10 Degrees Celsius
Regulatory Flags# DUNS number 079226220 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00630414287201 Atellica HEMA Calibrator Siemens Healthcare Diagnostics Inc. KRZ 2026-02-06 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 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 30844509000243 Cal-Chex STRECK, INC. KRZ 2016-09-16 30844509000311 Cal-Chex A Plus STRECK, INC. KRZ 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 00812137010223 Boule Cal CLINICAL DIAGNOSTIC SOLUTIONS, INC. KRZ 2016-09-06 00812137010360 CDS Hematology Calibrator CLINICAL DIAGNOSTIC SOLUTIONS, INC. KRZ 2016-09-02 00812137010421 CDS Hematology Calibrator CLINICAL DIAGNOSTIC SOLUTIONS, INC. KRZ 2016-09-02 00380740017071 CELL-DYN ABBOTT LABORATORIES KRZ 2016-06-06
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