RESOLVE Systems Neonatal Hemoglobin Kit FR-9400

GUDID 06438147000814

For detection of normal and variant hemoglobins.

Wallac Oy

Multiple haemoglogbin subtype IVD, kit, electrophoresis

• Primary Device ID: 06438147000814
• NIH Device Record Key: 2b0ebc83-3457-4795-aece-be017220fa34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESOLVE Systems Neonatal Hemoglobin Kit
• Version Model Number: FR-9400
• Catalog Number: FR-9400
• 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	06438147000814 [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 Neonatal Hemoglobin Kit]

• 06438147000814: For detection of normal and variant hemoglobins.
• 06438147000791: For detection of normal and variant hemoglobins.