RESOLVE Hb FACS Control kit

Basic Information

• Brand Name: RESOLVE Hb FACS Control kit
• Primary DI: 06438147385478
• Version / Model: 3412-0010
• Catalog Number: 3412-0010
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-17
• Public Version: 1
• Public Version Date: 2023-04-25
• Public Version Status: New
• Public Device Record Key: 6dfd6fe6-c8ca-4ffe-af89-f82757e24474

Device Description

A control for monitoring assay performance in isoelectric focusing techniques used for identifying hemoglobin variants.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
JCM	Control, Hemoglobin, Abnormal	Hematology	864.7415	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55876	Multiple haemoglobin subtype IVD, kit, electrophoresis	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of multiple subtypes of haemoglobin in a clinical specimen, using an electrophoresis method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438147385478	GS1

Storage Conditions

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