AccessGUDID - DEVICE: Herpes Simplex Virus Antigen Control Slide, 4 wells (B110QHS35040)

GUDID

Device Identifier (DI) Information

Brand Name: Herpes Simplex Virus Antigen Control Slide, 4 wells
Version or Model: QHS-3504
Commercial Distribution Status: In Commercial Distribution
Catalog Number: QHS-3504
Company Name: Bion Enterprises, Ltd.

Primary DI Number: B110QHS35040
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024824641 *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:	Yes
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?
52840	Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control	A material which is used to verify the performance of an assay 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJG	Quality Control Slides

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K890616	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: less than 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0df74411-72c7-42df-9231-954deb7135b7
Public Version Date: March 04, 2020
Public Version Number: 4
DI Record Publish Date: September 12, 2016