ONLINE TDM Acetaminophen Gen.2 08056684190

GUDID 07613336120934

Roche Diagnostics GmbH

Acetaminophen IVD, kit, enzyme spectrophotometry Acetaminophen IVD, kit, spectrophotometry Acetaminophen IVD, kit, spectrophotometry Acetaminophen IVD, kit, spectrophotometry Acetaminophen IVD, kit, spectrophotometry Acetaminophen IVD, kit, spectrophotometry Acetaminophen IVD, kit, spectrophotometry Acetaminophen IVD, kit, spectrophotometry Acetaminophen IVD, kit, spectrophotometry Acetaminophen IVD, kit, spectrophotometry Acetaminophen IVD, kit, spectrophotometry Acetaminophen IVD, kit, spectrophotometry Acetaminophen IVD, kit, spectrophotometry Acetaminophen IVD, kit, spectrophotometry Acetaminophen IVD, kit, spectrophotometry Acetaminophen IVD, kit, spectrophotometry

• Primary Device ID: 07613336120934
• NIH Device Record Key: 0dd7e350-6719-425a-b5e1-17d62888d48e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONLINE TDM Acetaminophen Gen.2
• Version Model Number: 08056684190
• Catalog Number: 08056684190
• 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	07613336120934 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141928

FDA Product Code

• LDP: COLORIMETRY, ACETAMINOPHEN

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