Duns Number:039981550
Device Description: SP4 Broth with Arginine, for Mycoplasma and Ureaplasma, 2ml, 13x100mm tube, optically clea SP4 Broth with Arginine, for Mycoplasma and Ureaplasma, 2ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20For the selective cultivation and differentiation of the mycoplasmas; including M. hominis, M. pneumoniae, and Ureaplasma urealyticum.
Catalog Number
R85
Brand Name
N/A
Version/Model Number
R85
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
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
2ec46929-c402-4b97-89a1-0b540b8d0462
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 |