Homocysteine Enzymatic Assay 5385415190

GUDID 04015630927326

Roche Diagnostics GmbH

Homocysteine IVD, kit, spectrophotometry

• Primary Device ID: 04015630927326
• NIH Device Record Key: 804cca5e-bbd5-4465-b86f-fd3eb0a1b967
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Homocysteine Enzymatic Assay
• Version Model Number: 5385415190
• Catalog Number: 5385415190
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630927326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113793

FDA Product Code

• LPS: URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM

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: 2023-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [Homocysteine Enzymatic Assay]

• 07613336121290: 08057826190
• 04015630933631: 5385377160
• 04015630929979: 6542921190
• 04015630927326: 5385415190