Tina-quant alpha1-Antitrypsin 11557599316

GUDID 04015630906758

Roche Diagnostics GmbH

Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 04015630906758
• NIH Device Record Key: c0bb224a-24bb-4e82-8a27-b2710f4cabf8
• Commercial Distribution Discontinuation: 2019-02-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Tina-quant alpha1-Antitrypsin
• Version Model Number: 11557599316
• Catalog Number: 11557599316
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: 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

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
• 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
• 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	04015630906758 [Primary]

FDA Product Code

• DEM: ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL

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: 2021-02-15
• Device Publish Date: 2016-09-20

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