ZEUS ELISA VZV IgM 480 Test System 9Z9331MB

GUDID 00845533001885

The ZEUS ELISA Varicella-Zoster Virus (VZV) IgM Test System is intended for the qualitative detection of VZV IgM antibody inhuman sera as an aid in the diagnosis of primary infection or reactivation. The assay performance in detecting antibodies to VZVin individuals vaccinated with the FDA licensed VZV vaccine is unknown. The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals. The assay performance in detecting antibodies to VZV in cord bloodand neonates has not been established.

ZEUS SCIENTIFIC, INC.

Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00845533001885
• NIH Device Record Key: 262ef954-ca0f-448d-b898-81052f2faf90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZEUS ELISA VZV IgM 480 Test System
• Version Model Number: 9Z9331MB
• Catalog Number: 9Z9331MB
• 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
• 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	00845533001885 [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: 2024-09-26
• Device Publish Date: 2024-09-18

Devices Manufactured by ZEUS SCIENTIFIC, INC.

• 00845533001885 - ZEUS ELISA VZV IgM 480 Test System: 2024-09-26The ZEUS ELISA Varicella-Zoster Virus (VZV) IgM Test System is intended for the qualitative detection of VZV IgM antibody inhuman sera as an aid in the diagnosis of primary infection or reactivation. The assay performance in detecting antibodies to VZVin individuals vaccinated with the FDA licensed VZV vaccine is unknown. The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals. The assay performance in detecting antibodies to VZV in cord bloodand neonates has not been established.
• 00845533001885 - ZEUS ELISA VZV IgM 480 Test System: 2024-09-26 The ZEUS ELISA Varicella-Zoster Virus (VZV) IgM Test System is intended for the qualitative detection of VZV IgM antibody inhuma
• 00845533001878 - ZEUS NTx Urine: 2023-04-26 An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen
• 00845533001861 - ZEUS dIFine(R): 2022-05-11 ZEUS dIFine® digital immunofluorescence system is an IFA imaging and pattern recognition instrument designed to acquire, analyz
• 00845533001854 - ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test System: 2022-05-05 The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodi
• 00845533000031 - AtheNA Multi-Lyte® EBV IgG Plus Test System: 2019-02-21 The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus (EBV) IgG Plus Test System is intended for the qualitative detection of IgG clas
• 00845533000048 - AtheNA Multi-Lyte® EBV-VCA IgM Plus Test System: 2019-02-21 The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus - Viral Capsid Antigen (EBV-VCA) IgM Plus Test System is a microparticle-based i
• 00845533000499 - ELISA EBV-VCA IgM Test System: 2019-02-21 The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA)
• 00845533000505 - ELISA EBV-VCA IgM Q Test System: 2019-02-21 The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA)