AccessGUDID - DEVICE: MERIFLUOR VZV (Vericella-Zoster Virus) (00840733101212)

GUDID

Device Identifier (DI) Information

Brand Name: MERIFLUOR VZV (Vericella-Zoster Virus)
Version or Model: 500113
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 500113
Company Name: MERIDIAN BIOSCIENCE, INC.

Primary DI Number: 00840733101212
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092815364 *Terms of Use

Device Description: MERIFLUOR VZV is an in vitro direct immunofluorescent detection procedure for the detection of varicella-zoster virus (VZV) in vesicle smears and biopsy specimens. in addition, the reagent can be used to confirm the presence of VZV in cell culture.

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):	Yes
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?
49615	Varicella-zoster virus (VZV) antigen IVD, kit, direct fluorescent test (DFT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from varicella-zoster virus (VZV) in a clinical specimen, using a direct fluorescent test (DFT).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GQX	Antiserum, Cf, Varicella-Zoster

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K841526	000

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
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e735a67b-0db8-4815-8553-eaa5d2825f26
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016