AccessGUDID - DEVICE: Simplexa™ HSV 1 & 2 Direct (20816101025507)

GUDID

Device Identifier (DI) Information

Brand Name: Simplexa™ HSV 1 & 2 Direct
Version or Model: MOL2150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MOL2150
Company Name: DIASORIN MOLECULAR LLC

Primary DI Number: 20816101025507
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080271715 *Terms of Use

Device Description: No description.

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
PGH	Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN130049	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
Storage Environment Temperature: between -30 and -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fdb2e734-0d07-4c39-a31b-5c2d0d10effb
Public Version Date: July 08, 2024
Public Version Number: 4
DI Record Publish Date: September 22, 2016