AccessGUDID - DEVICE: Light Diagnostics SimulFluor HSV 1/2 (04053252515101)

GUDID

Device Identifier (DI) Information

Brand Name: Light Diagnostics SimulFluor HSV 1/2
Version or Model: 5243-2mL
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5243-2mL
Company Name: EMD Millipore Corporation

Primary DI Number: 04053252515101
Issuing Agency: GS1
Commercial Distribution End Date: April 28, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 829517072 *Terms of Use

Device Description: Light Diagnostics SimulFluor HSV 1/2

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?
49537	Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GQN	Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991880	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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3e129e46-200e-4c33-a2b8-8e1ab711ce55
Public Version Date: August 25, 2023
Public Version Number: 2
DI Record Publish Date: April 16, 2020