AccessGUDID - DEVICE: InTray® COLOREX Screen (B08811030)

GUDID

Device Identifier (DI) Information

Brand Name: InTray® COLOREX Screen
Version or Model: 1103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21-103-001
Company Name: BIO-MED DIAGNOSTICS, INC.

Primary DI Number: B08811030
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 605213545 *Terms of Use

Device Description: For rapid isolation and differentiation of urinary tract pathogens. Suitable for direct plating of urine specimens.

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):	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?
62908	Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple pathogens associated with urinary tract infection, isolated by culture from a clinical specimen, and requiring less incubation time than standard laboratory methods. Organisms may include (but are not limited to) Escherichia coli, Proteus mirabilis, Klebsiella, Staphylococcus aureus, and Candida albicans.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSI	Culture Media, Selective And Differential

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 26a11ca3-db34-4564-8a57-a5058f8a7ee6
Public Version Date: October 15, 2018
Public Version Number: 1
DI Record Publish Date: September 13, 2018