AccessGUDID - DEVICE: ELISA VZV IgM Q Test System (00845533001311)

GUDID

Device Identifier (DI) Information

Brand Name: ELISA VZV IgM Q Test System
Version or Model: Q9Z9331MB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Q9Z9331MB
Company Name: ZEUS SCIENTIFIC, INC.

Primary DI Number: 00845533001311
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080953946 *Terms of Use

Device Description: The ZEUS ELISA Varicella-Zoster Virus (VZV) IgM Test System is intended for the qualitative detection of VZV IgM antibody in human sera as an aid in the diagnosis of primary infection or reactivation. The assay performance in detecting antibodies to VZV in 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 blood and neonates has not been established.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
49627	Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to varicella-zoster virus (VZV) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 81b1d73c-8ed8-41cb-9181-9466d4f78412
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016