GSP Neonatal Total Galactose kit 3309-002U

GUDID 06438147367917

For the quantitative determination of total galactose concentration in dried blood. Note: Kit contains multiple packages.

Wallac Oy

Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence Total galactose IVD, kit, enzyme fluorescence

• Primary Device ID: 06438147367917
• NIH Device Record Key: 0ba67f14-b1a3-4784-ac1e-b003aeb99b73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GSP Neonatal Total Galactose kit
• Version Model Number: 3309-002U
• Catalog Number: 3309-002U
• 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 -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147367917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190335

FDA Product Code

• JIA: Enzymatic Methods, Galactose

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: 2021-06-14
• Device Publish Date: 2021-06-04

On-Brand Devices [GSP Neonatal Total Galactose kit]

• 06438147328031: For the quantitative determination of total galactose concentration in dried blood. Note: Kit co
• 06438147367917: For the quantitative determination of total galactose concentration in dried blood. Note: Kit co