ACCURUN® 365 Series 200 2020-0107

GUDID 00816784020901

ACCURUN® 365 Series 200 West Nile Virus Positive Control 10 x 1.5 mL per vial.

SERACARE LIFE SCIENCES, INC.

West Nile virus nucleic acid IVD, control

• Primary Device ID: 00816784020901
• NIH Device Record Key: fb29cb44-16c2-4e15-a426-4af96d52c9b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCURUN® 365 Series 200
• Version Model Number: 2020-0107
• Catalog Number: 2020-0107
• Company DUNS: 106267123
• Company Name: SERACARE LIFE SCIENCES, INC.
• 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: true
• 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 -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816784020901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK060022

FDA Product Code

• MYZ: Kit, Test (Donors), For Bloodborne Pathogen

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: 2020-09-01
• Device Publish Date: 2020-08-24

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