Sickle-Heme

Primary DI
00860003629901
Brand
Sickle-Heme
Company
GREAT LAKES DIAGNOSTICS, INC.
Model
GLD-100
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
CodeName
GHMTest, Sickle Cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHMTest, Sickle CellHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003629901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003629901008600036299018600036299010860003629901

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin S (HbS) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of haemoglobin subtype S (HbS), also known as sickle cell haemoglobin, in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
804870996
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003629918Sickle-HemeGLD-250GLD-2502021-12-13
00860003629925Sickle-HemeGLD-1GLD-12021-12-13
00860003629932Sickle-HemeGLD-20GLD-202021-12-13
00860003629949Sickle-HemeGLD-122021-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003629918Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00860003629925Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00860003629932Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00860003629949Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00630414976341Dade® Sickle-Sol TestSiemens Healthcare Diagnostics Products GmbHGHM2016-09-24
00630414976365Dade® Sickle-Sol TestSiemens Healthcare Diagnostics Products GmbHGHM2016-09-24
00844509000884Sickle-ChexSTRECK, INC.GHM2016-09-19
00844509000891Sickle-ChexSTRECK, INC.GHM2016-09-19
00844509002024SICKLEDEXSTRECK, INC.GHM2016-09-19
00844509002031SICKLEDEXSTRECK, INC.GHM2016-09-19
00844509002048SICKLEDEXSTRECK, INC.GHM2016-09-19
00845275000740Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHM2016-09-16
00845275000757Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHM2016-09-16
00845275000733Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHM2016-07-19
00816057020003ASI Sickle Cell TestARLINGTON SCIENTIFIC, INC.GHM2016-07-08
00816057020010ASI Sickle Cell TestARLINGTON SCIENTIFIC, INC.GHM2016-07-08
00816057020027ASI Sickle Cell TestARLINGTON SCIENTIFIC, INC.GHM2016-07-08
00816057020034ASI Sickle Cell TestARLINGTON SCIENTIFIC, INC.GHM2016-07-08