Tina-quant Hemoglobin A1cDx Gen.3 08445699190

GUDID 07613336157824

Roche Diagnostics GmbH

Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 07613336157824
• NIH Device Record Key: 8f95ddfc-d218-4646-a3fa-204555dc665d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tina-quant Hemoglobin A1cDx Gen.3
• Version Model Number: 08445699190
• Catalog Number: 08445699190
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336157824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193053

FDA Product Code

• LCP: ASSAY, GLYCOSYLATED HEMOGLOBIN

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: 2020-04-22
• Device Publish Date: 2020-04-14

On-Brand Devices [Tina-quant Hemoglobin A1cDx Gen.3]

• 07613336157824: 08445699190
• 07613336120927: 08056668190