Duns Number:039981550
Device Description: FLN (Florescence-Lactose-Dentrification) Agar Slant for NFB (Non-Fermentative Gram Negativ FLN (Florescence-Lactose-Dentrification) Agar Slant for NFB (Non-Fermentative Gram Negative Bacilli), 13x100mm tube, order by the package of 10For the identification of non-fermentative bacilli by fluorscein pigment production, lactose utilization, and nitrate reduction. See technical insert.
Catalog Number
Y22
Brand Name
N/A
Version/Model Number
Y22
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 06, 2022
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JSH
Product Code Name
Culture Media, Non-Selective And Differential
Public Device Record Key
1a726511-57fe-4969-91fa-31df3af6e55f
Public Version Date
April 07, 2022
Public Version Number
2
DI Record Publish Date
June 09, 2020
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 | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |