Anti-EBV VCA IgM SM9Z9201M

GUDID 00845533002738

The ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human sera. The Test System is intended to be used for the diagnosis of EBV-associated infectious mononucleosis when used in conjunction with other EBV serological assays. This test is for In Vitro diagnostic use only.

ZEUS SCIENTIFIC, INC.

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00845533002738
• NIH Device Record Key: c4a85b99-d618-477f-8a69-a6351c247761
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-EBV VCA IgM
• Version Model Number: SM9Z9201M
• Catalog Number: SM9Z9201M
• Company DUNS: 080953946
• Company Name: ZEUS SCIENTIFIC, 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533002738 [Primary]

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: 2026-01-23
• Device Publish Date: 2026-01-15

On-Brand Devices [Anti-EBV VCA IgM]

• 00845533002738: The ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM is an enzyme-linked immunosorben
• 00845533002721: The Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM is an enzyme-linked immunosorbent assa