AccessGUDID - DEVICE: HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive Control (10816101021021)

GUDID

Device Identifier (DI) Information

Brand Name: HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive Control
Version or Model: IB0913
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IB0913
Company Name: DIASORIN MOLECULAR LLC

Primary DI Number: 10816101021021
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:	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?
49542	Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot	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 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using an immunoblot assay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGC	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K000238	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: a30822bf-7e2e-46ea-b25d-332cf51bc1d9
Public Version Date: July 04, 2024
Public Version Number: 4
DI Record Publish Date: September 22, 2016