Duns Number:299579792
Device Description: MYCOFAST US has been designed for the detection, enumeration and identification of Ureapla MYCOFAST US has been designed for the detection, enumeration and identification of Ureaplasma urealyticum (U.u.) and Mycoplasma hominis (M.h.) in various clinical sspecimens.
Catalog Number
00050
Brand Name
MYCOFAST US
Version/Model Number
00050
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JTO
Product Code Name
Discs, Strips And Reagents, Microorganism Differentiation
Public Device Record Key
a838bea4-92b1-43d3-bcb6-c175a071be12
Public Version Date
January 10, 2019
Public Version Number
1
DI Record Publish Date
December 10, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |