Duns Number:039981550
Device Description: LIM Broth, 2ml fill, 12x80mm plastic tube with red cap, order by the package of 100For the LIM Broth, 2ml fill, 12x80mm plastic tube with red cap, order by the package of 100For the selective enrichment of Group B Streptococcus (Streptococcus agalactiae) from clinical specimens in a container compatible in the WASP instrument.
Catalog Number
R73BX
Brand Name
N/A
Version/Model Number
R73BX
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JSD
Product Code Name
Culture Media, Selective Broth
Public Device Record Key
5575d579-a5a7-45b8-b81b-0b2057dd6bb6
Public Version Date
June 15, 2020
Public Version Number
1
DI Record Publish Date
June 05, 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 |