AccessGUDID - DEVICE: Mutlicode®-RTx HSV 1&2 Kit (00840487101032)

GUDID

Device Identifier (DI) Information

Brand Name: Mutlicode®-RTx HSV 1&2 Kit
Version or Model: 3711
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3711
Company Name: LUMINEX CORPORATION

Primary DI Number: 00840487101032
Issuing Agency: GS1
Commercial Distribution End Date: January 21, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 079686463 *Terms of Use

Device Description: The MultiCode®-RTx Herpes Simplex Virus 1 & 2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV 1 & 2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes 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):	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?
49539	Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials 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, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OQO	Herpes simplex virus nucleic acid amplification assay

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 -30 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ac88ffb3-3cf1-453b-b549-3f3a4eb8fe0c
Public Version Date: January 22, 2021
Public Version Number: 3
DI Record Publish Date: September 09, 2016