ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 2000

GUDID 00816784020970

ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 2000

SERACARE LIFE SCIENCES, INC.

SARS-CoV-2 total antibody IVD, control

• Primary Device ID: 00816784020970
• NIH Device Record Key: c173064f-99bd-4c6a-8432-ed5f8e8f69c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 2000
• Version Model Number: 2015-0225
• 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: false
• Lot Batch: true
• Serial Number: true
• 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 Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Humidity: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816784020970 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2020-12-11
• Device Publish Date: 2020-12-03

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