AccessGUDID - DEVICE: InTray™ GC (B08810800)

GUDID

Device Identifier (DI) Information

Brand Name: InTray™ GC
Version or Model: 1080
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-8000
Company Name: BIO-MED DIAGNOSTICS, INC.

Primary DI Number: B08810800
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 605213545 *Terms of Use

Device Description: Intended for use in the qualitative detection of oral, rectal and genitourethral Neisseria gonorrhoeae colonization.

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?
52806	Neisseria gonorrhoeae culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of Neisseria gonorrhoeae bacteria, the causative agent of gonorrhoea which has been isolated by culture from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTY	Culture Media, For Isolation Of Pathogenic Neisseria

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993033	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: baeb33b4-58fa-41da-87f0-6e6f3ba1dc3f
Public Version Date: July 18, 2019
Public Version Number: 4
DI Record Publish Date: September 21, 2016