RESOLVE Systems Hb Elution Solution 3024-0010

GUDID 06438147246120

For in vitro use with the RESOLVE Hemoglobin Kits for isoelectric focusing.

Wallac Oy

Multiple haemoglogbin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis

• Primary Device ID: 06438147246120
• NIH Device Record Key: e4cc329c-ddd2-449f-91c4-41de1fec490c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESOLVE Systems Hb Elution Solution
• Version Model Number: 3024-0010
• Catalog Number: 3024-0010
• Company DUNS: 540156544
• Company Name: Wallac Oy
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147246120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050709

FDA Product Code

• GKA: Abnormal Hemoglobin Quantitation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-28
• Device Publish Date: 2016-02-02

On-Brand Devices [RESOLVE Systems Hb Elution Solution]

• 06438147246137: For in vitro use with the RESOLVE Hemoglobin Kits for isoelectric focusing.
• 06438147246120: For in vitro use with the RESOLVE Hemoglobin Kits for isoelectric focusing.