AccessGUDID - DEVICE: InTray® COLOREX Salmonella (B08812230)

GUDID

Device Identifier (DI) Information

Brand Name: InTray® COLOREX Salmonella
Version or Model: 1223
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21-223-001
Company Name: BIO-MED DIAGNOSTICS, INC.

Primary DI Number: B08812230
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 605213545 *Terms of Use

Device Description: A chromogenic medium for selective isolation and differentiation of Salmonella species, (e.g., Enterobacteriaceae and other enteric bacteria).The test can be performed with samples composed of mixed populations of bacteria, e.g stool, blood, biological fluids, surface streaks, etc. High sensitivity and specificity of the medium lead to a higher detection rate of Salmonella spp. Selective agents inhibit the growth of gram-positive organisms. Artificial substrates are metabolized by specific microbial enzymes liberating insoluble chromogenic compounds. Salmonella species produce deep pink to mauve colored colonies. Bacteria other than Salmonella spp. produce blue colonies, or are colorless or inhibited.

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?
58571	Chromogenic Salmonella species agar culture medium IVD	A selective and/or differential agar culture medium containing chromogenic substrates intended to be used for the growth and isolation of Salmonella species from a clinical specimen.	Obsolete	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: 336b8a3b-a6ce-4af2-ab95-6a0b20d0e18d
Public Version Date: October 15, 2018
Public Version Number: 1
DI Record Publish Date: September 12, 2018