AccessGUDID - DEVICE: HSV 1&2 ELITe MGB Assay for CE-IVD (03661540951947)

GUDID

Device Identifier (DI) Information

Brand Name: HSV 1&2 ELITe MGB Assay for CE-IVD
Version or Model: RTK403ING
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RTK403ING
Company Name: Elitechgroup Mdx LLC

Primary DI Number: 03661540951947
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117458512 *Terms of Use

Device Description: The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
52790	Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOI	Real Time Nucleic Acid Amplification System

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 05c91df0-f11e-4dd6-bae7-d58f3f885b38
Public Version Date: October 15, 2020
Public Version Number: 2
DI Record Publish Date: September 15, 2020