Accutrend Plus Cholesterol strips 05213312160

GUDID 00365702276109

Roche Diagnostics GmbH

Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent

• Primary Device ID: 00365702276109
• NIH Device Record Key: c6f8cfdb-398f-46e0-a77e-0656737e15e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accutrend Plus Cholesterol strips
• Version Model Number: 05213312160
• Catalog Number: 05213312160
• 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: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00365702276109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051376

FDA Product Code

• CHH: Enzymatic Esterase--Oxidase, Cholesterol

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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