Sickle-Heme

Basic Information

• Brand Name: Sickle-Heme
• Primary DI: 00860003629925
• Version / Model: GLD-1
• Catalog Number: GLD-1
• Company Name: GREAT LAKES DIAGNOSTICS, INC.
• Labeler DUNS: 804870996
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-13
• Public Version: 1
• Public Version Date: 2021-12-22
• Public Version Status: New
• Public Device Record Key: f53c19d0-4658-4209-affd-40ff88608455

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GHM	Test, Sickle Cell	Hematology	864.7825	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56232	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003629925	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius