Duns Number:605213545
Device Description: For isolation and differentiation of major clinically significant Candida species. Suitabl For isolation and differentiation of major clinically significant Candida species. Suitable for direct streaking of samples from skin,sputum, urine or genitourinary swabs.
Catalog Number
21-113-001
Brand Name
InTray® COLOREX Yeast
Version/Model Number
1113
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
778b0a3a-2386-49bf-83d5-86d081c425b8
Public Version Date
October 15, 2018
Public Version Number
1
DI Record Publish Date
September 13, 2018
Package DI Number
B08811134
Quantity per Package
20
Contains DI Package
B08811130
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box