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 West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control West Nile virus nucleic acid IVD, control 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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