Home GUDID 00860003629925
Sickle-Heme
Primary DI 00860003629925
Brand Sickle-Heme
Company GREAT LAKES DIAGNOSTICS, INC.
Model GLD-1
Catalog number GLD-1
Device description A positive and negative lyophilized whole blood control to test for the presence of Hemoglobin S in solubility tests. Contains 2 Positive control vials and 2 Negative control vials.
Published 2021-12-13
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 GHM Test, Sickle Cell
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GHM Test, Sickle Cell Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860003629925 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 00860003629925 00860003629925 860003629925 0860003629925
GMDN Terms# Term, Definition table Term Definition Haemoglobin S (HbS) IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype S (HbS), also known as sickle cell haemoglobin, in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 804870996 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 00860003629901 Sickle-Heme GREAT LAKES DIAGNOSTICS, INC. GHM 2021-12-13 00860003629918 Sickle-Heme GREAT LAKES DIAGNOSTICS, INC. GHM 2021-12-13 00860003629932 Sickle-Heme GREAT LAKES DIAGNOSTICS, INC. GHM 2021-12-13 00860003629949 Sickle-Heme GREAT LAKES DIAGNOSTICS, INC. GHM 2021-12-13 00630414976341 Dade® Sickle-Sol Test Siemens Healthcare Diagnostics Products GmbH GHM 2016-09-24 00630414976365 Dade® Sickle-Sol Test Siemens Healthcare Diagnostics Products GmbH GHM 2016-09-24 00844509000884 Sickle-Chex STRECK, INC. GHM 2016-09-19 00844509000891 Sickle-Chex STRECK, INC. GHM 2016-09-19 00844509002024 SICKLEDEX STRECK, INC. GHM 2016-09-19 00844509002031 SICKLEDEX STRECK, INC. GHM 2016-09-19 00844509002048 SICKLEDEX STRECK, INC. GHM 2016-09-19 00845275000740 Thermo Scientific Pacific Hemostasis® Fisher Diagnostics GHM 2016-09-16 00845275000757 Thermo Scientific Pacific Hemostasis® Fisher Diagnostics GHM 2016-09-16 00845275000733 Thermo Scientific Pacific Hemostasis® Fisher Diagnostics GHM 2016-07-19 00816057020003 ASI Sickle Cell Test ARLINGTON SCIENTIFIC, INC. GHM 2016-07-08 00816057020010 ASI Sickle Cell Test ARLINGTON SCIENTIFIC, INC. GHM 2016-07-08 00816057020027 ASI Sickle Cell Test ARLINGTON SCIENTIFIC, INC. GHM 2016-07-08 00816057020034 ASI Sickle Cell Test ARLINGTON SCIENTIFIC, INC. GHM 2016-07-08