Duns Number:276816717
Device Description: selective agar plate for screening and aid to diagnosis by isolation of NTM colonies from selective agar plate for screening and aid to diagnosis by isolation of NTM colonies from sputum samples from cystic fibrosis patients and from respiratory specimens from non-cystic fibrosis patients
Catalog Number
-
Brand Name
NTM Elite agar
Version/Model Number
NTM Elite agar
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
Yes
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
JSI
Product Code Name
CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL
Public Device Record Key
de16b0e3-c94a-4bab-b5dc-c7f8c879f043
Public Version Date
June 15, 2020
Public Version Number
1
DI Record Publish Date
June 05, 2020
Package DI Number
03573026609856
Quantity per Package
2
Contains DI Package
03573026609801
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |