Neonatal Biotinidase kit 3018-0010

GUDID 06438147291342

For the semi-quantitative determination of biotinidase in dried blood. Note: Kit contains multiple packages.

Wallac Oy

Biotinidase IVD, kit, enzyme fluorescence

• Primary Device ID: 06438147291342
• NIH Device Record Key: 870401a6-f292-4fb6-ae19-c11fc2eeaa7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neonatal Biotinidase kit
• Version Model Number: 3018-0010
• Catalog Number: 3018-0010
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147291342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090123

FDA Product Code

• NAK: System,Test,Biotinidase

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-01-12

On-Brand Devices [Neonatal Biotinidase kit]

• 06438147291359: For the semi-quantitative determination of biotinidase in dried blood. Note: Kit contains multip
• 06438147291342: For the semi-quantitative determination of biotinidase in dried blood. Note: Kit contains multip