Sickle-Heme GLD-20

GUDID 00860003629932

A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human blood or sickle cell control material. Contains 20 tests.

GREAT LAKES DIAGNOSTICS, INC.

Haemoglobin S (HbS) IVD, reagent

• Primary Device ID: 00860003629932
• NIH Device Record Key: 22035088-d638-480b-ac94-29f534a24da4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sickle-Heme
• Version Model Number: GLD-20
• Catalog Number: GLD-20
• Company DUNS: 804870996
• Company Name: GREAT LAKES DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 248.307.9494
• Email: customerservice@greatlakesdiag.com
• Phone: 248.307.9494
• Email: customerservice@greatlakesdiag.com
• Phone: 248.307.9494
• Email: customerservice@greatlakesdiag.com
• Phone: 248.307.9494
• Email: customerservice@greatlakesdiag.com
• Phone: 248.307.9494
• Email: customerservice@greatlakesdiag.com
• Phone: 248.307.9494
• Email: customerservice@greatlakesdiag.com
• Phone: 248.307.9494
• Email: customerservice@greatlakesdiag.com
• Phone: 248.307.9494
• Email: customerservice@greatlakesdiag.com
• Phone: 248.307.9494
• Email: customerservice@greatlakesdiag.com
• Phone: 248.307.9494
• Email: customerservice@greatlakesdiag.com
• Phone: 248.307.9494
• Email: customerservice@greatlakesdiag.com
• Phone: 248.307.9494
• Email: customerservice@greatlakesdiag.com
• Phone: 248.307.9494
• Email: customerservice@greatlakesdiag.com
• Phone: 248.307.9494
• Email: customerservice@greatlakesdiag.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003629932 [Primary]

FDA Product Code

• GHM: Test, Sickle Cell

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-22
• Device Publish Date: 2021-12-13

On-Brand Devices [Sickle-Heme]

• 00860003629949: A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human b
• 00860003629932: A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human b
• 00860003629925: A positive and negative lyophilized whole blood control to test for the presence of Hemoglobin S
• 00860003629918: A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human b
• 00860003629901: GLD-100