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 ID00845533001885
NIH Device Record Key262ef954-ca0f-448d-b898-81052f2faf90
Commercial Distribution StatusIn Commercial Distribution
Brand NameZEUS ELISA VZV IgM 480 Test System
Version Model Number9Z9331MB
Catalog Number9Z9331MB
Company DUNS080953946
Company NameZEUS SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100845533001885 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-26
Device Publish Date2024-09-18

Devices Manufactured by ZEUS SCIENTIFIC, INC.

00845533002721 - Anti-EBV VCA IgM2026-01-23 The Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM is an enzyme-linked immunosorbent assay (ELISA) designed for the quali
00845533002738 - Anti-EBV VCA IgM2026-01-23 The ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM is an enzyme-linked immunosorbent assay (ELISA) designed for the
00845533002745 - Anti-PR32026-01-23 The Anti Proteinase-3 (PR-3) is intended for the qualitative and semi-quantitative detection of IgG-class antibody to proteninas
00845533002752 - Anti-PR32026-01-23 The Anti Proteinase-3 (PR-3) Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody t
00845533002769 - Anti-Sm2026-01-23 The Anti Sm Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Sm in human sera. When perform
00845533002776 - Anti-Sm2026-01-23 The Anti Sm Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Sm in human sera. When perform
00845533002783 - Anti-SSA (Ro)2026-01-23 The Anti SSA (Ro) is a semi-quantitative immunoassay for the detection of IgG antibodies to SSA in human sera. When performed ac
00845533002790 - Anti-SSA (Ro)2026-01-23 The Anti SSA (Ro) is a semi-quantitative immunoassay for the detection of IgG antibodies to SSA in human sera. When performed ac
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.