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

Contact Domains#

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
00860003629925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003629925008600036299258600036299250860003629925

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin S (HbS) IVD, controlA 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
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
248.307.9494customerservice@greatlakesdiag.com

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
00860003629901Sickle-HemeGLD-1002021-12-13
00860003629918Sickle-HemeGLD-250GLD-2502021-12-13
00860003629932Sickle-HemeGLD-20GLD-202021-12-13
00860003629949Sickle-HemeGLD-122021-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003629901Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00860003629918Sickle-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