Tina-quant Alpha 1-Acid Glycoprotein Gen.2 5991960190

GUDID 04015630928408

Roche Diagnostics GmbH

Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 04015630928408
• NIH Device Record Key: 88a2d7e1-f43a-4f1c-a99a-c9f6bc6bd858
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tina-quant Alpha 1-Acid Glycoprotein Gen.2
• Version Model Number: 5991960190
• Catalog Number: 5991960190
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630928408 [Primary]

FDA Product Code

• LKL: ALPHA-1-ACID-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROL

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: 2021-01-26
• Device Publish Date: 2021-01-18

On-Brand Devices [Tina-quant Alpha 1-Acid Glycoprotein Gen.2]

• 04015630928408: 5991960190
• 04015630919529: 3333795190