ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL

GUDID 00816784020925

ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL

SERACARE LIFE SCIENCES, INC.

Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control Hepatitis B virus antigen/antibody marker IVD, control

• Primary Device ID: 00816784020925
• NIH Device Record Key: d57ec337-31c4-44c9-971d-a19699f97522
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL
• Version Model Number: 2000-0065
• Company DUNS: 106267123
• Company Name: SERACARE LIFE SCIENCES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816784020925 [Primary]

FDA Product Code

• DGQ: Whole Blood Plasma, Antigen, Antiserum, Control

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: 2021-08-26
• Device Publish Date: 2021-08-18

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