AccuPlex™ 0505-0001

GUDID 00816784020017

AccuPlex rEbola GP/NP Reference Material 5 x 0.25 mL

SERACARE LIFE SCIENCES, INC.

Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control Ebola virus nucleic acid IVD, control

• Primary Device ID: 00816784020017
• NIH Device Record Key: e0e1d0dc-8f0d-4962-b38e-a87997afd010
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuPlex™
• Version Model Number: 0505-0001
• Catalog Number: 0505-0001
• 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

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816784020017 [Primary]

FDA Product Code

• DGR: Whole Human Serum, Antigen, Antiserum, Control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-11

Devices Manufactured by SERACARE LIFE SCIENCES, INC.

• 00816784020925 - ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL: 2021-08-26 ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL
• 00816784020932 - ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 6 x 3.5 mL: 2021-08-26 ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 6 x 3.5 mL
• 00816784020963 - ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 1000: 2020-12-11 ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 1000
• 00816784020970 - ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 2000: 2020-12-11 ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 2000
• 00816784020987 - AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome: 2020-09-29 AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome (Positive and Negative member-5 X 1.5 ml)
• 00816784020901 - ACCURUN® 365 Series 200: 2020-09-01 ACCURUN® 365 Series 200 West Nile Virus Positive Control 10 x 1.5 mL per vial.
• 00816784020918 - AccuPlex™ SARS-CoV-2 Molecular Controls kit: 2020-07-17 AccuPlex™ SARS-CoV-2 Molecular Controls kit (Positive and Negative member-5 X 1.5 ml)
• 00816784020611 - ACCURUN®: 2020-06-29 ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 1.2 mL