RESOLVE Systems Hemoglobin Kit

Basic Information

• Brand Name: RESOLVE Systems Hemoglobin Kit
• Primary DI: 06438147000784
• Version / Model: FR-9120
• Catalog Number: FR-9120
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-02
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 65af0931-af19-4388-840b-128734b16138

Device Description

For detection of normal and variant hemoglobins.

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: 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
GKA	Abnormal Hemoglobin Quantitation	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	06438147000784	GS1

Premarket Submissions

Submission Number	Supplement Number
K050709	000

Storage Conditions

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