Tina-quant Albumin Gen.2 08056722190

GUDID 07613336120965

Roche Diagnostics GmbH

Albumin IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 07613336120965
• NIH Device Record Key: 6afcb9f3-9871-4de9-b72e-fa950d10757b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tina-quant Albumin Gen.2
• Version Model Number: 08056722190
• Catalog Number: 08056722190
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336120965 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101203

FDA Product Code

• JIR: INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)

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: 2020-03-13
• Device Publish Date: 2020-03-05

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