AccessGUDID - DEVICE: HerpeSelect® 2 ELISA IgG (20816101022186)

GUDID

Device Identifier (DI) Information

Brand Name: HerpeSelect® 2 ELISA IgG
Version or Model: EL0920G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EL0920G
Company Name: DIASORIN MOLECULAR LLC

Primary DI Number: 20816101022186
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?
49595	Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to herpes simplex virus 2 (HSV2) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYF	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993724	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: 7172ae88-312c-4279-8ebc-49c8a6438b2d
Public Version Date: July 04, 2024
Public Version Number: 4
DI Record Publish Date: September 22, 2016