a-Amylase EPS ver.2 08056811190

GUDID 07613336121009

Roche Diagnostics GmbH

Total amylase IVD, kit, enzyme spectrophotometry Total amylase IVD, kit, spectrophotometry Total amylase IVD, kit, spectrophotometry Total amylase IVD, kit, spectrophotometry Total amylase IVD, kit, spectrophotometry Total amylase IVD, kit, spectrophotometry Total amylase IVD, kit, spectrophotometry Total amylase IVD, kit, spectrophotometry Total amylase IVD, kit, spectrophotometry Total amylase IVD, kit, spectrophotometry Total amylase IVD, kit, spectrophotometry Total amylase IVD, kit, spectrophotometry Total amylase IVD, kit, spectrophotometry Total amylase IVD, kit, spectrophotometry Total amylase IVD, kit, spectrophotometry Total amylase IVD, kit, spectrophotometry

• Primary Device ID: 07613336121009
• NIH Device Record Key: e8028102-73af-491a-9937-7678e77da7b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: a-Amylase EPS ver.2
• Version Model Number: 08056811190
• Catalog Number: 08056811190
• 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	07613336121009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972250

FDA Product Code

• JFJ: CATALYTIC METHODS, AMYLASE

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

Devices Manufactured by Roche Diagnostics GmbH

• 07613336228623 - navify POC Operations: 2024-05-08
• 07613336224816 - ONLINE TDM Methotrexate: 2024-04-02
• 07613336224823 - ONLINE TDM Methotrexate: 2024-04-02
• 07613336224830 - MTX Calibrator: 2024-04-02
• 07613336217689 - Elecsys ProBNP II: 2024-02-27
• 04015630929702 - cobas Elecsys AntiTPO: 2024-02-16
• 04015630939626 - Elecsys Anti-TPO: 2024-02-16
• 04015630899548 - Elecsys CalSet TUptake: 2024-02-05