AutoDELFIA Neonatal IRT kit B005-212

GUDID 06438147298716

For the quantitative determination of immunoreactive trypsin (IRT) in dried blood.

Wallac Oy

Neonatal trypsin IVD, kit, fluorescent immunoassay

• Primary Device ID: 06438147298716
• NIH Device Record Key: 2e7e6bd1-728b-4b10-865e-b6343719f16d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoDELFIA Neonatal IRT kit
• Version Model Number: B005-212
• Catalog Number: B005-212
• 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 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147298716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110274

FDA Product Code

• JNO: N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin

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: 2016-02-02

On-Brand Devices [AutoDELFIA Neonatal IRT kit]

• 06438147298785: For the quantitative determination of immunoreactive trypsin (IRT) in dried blood.
• 06438147298716: For the quantitative determination of immunoreactive trypsin (IRT) in dried blood.