Duns Number:276816717
Device Description: Saline Solution is a diluent used for manual preparation of organism suspensions, prior to Saline Solution is a diluent used for manual preparation of organism suspensions, prior to identification and antimicrobial susceptibility processing with VITEK® 2 instruments.
Catalog Number
-
Brand Name
SALINE SOLUTION
Version/Model Number
SALINE SOLUTION
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
N50510,N50510
Product Code
LON
Product Code Name
SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Public Device Record Key
528c4711-96bb-4fa4-a532-6fbb0b1f53a4
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
February 10, 2022
Package DI Number
03573026617967
Quantity per Package
18
Contains DI Package
03573026617950
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 |