Duns Number:071674100
Catalog Number
08261598190
Brand Name
cobas PCR Media
Version/Model Number
08261598190
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"
Yes
For Single-Use
-
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
PPM
Product Code Name
General Purpose Reagent
Public Device Record Key
a5c84b67-55e9-4ef7-8a00-48c1dd3f86a4
Public Version Date
April 15, 2022
Public Version Number
2
DI Record Publish Date
July 01, 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 | 41 |
2 | A medical device with a moderate to high risk that requires special controls. | 48 |
3 | A medical device with high risk that requires premarket approval | 29 |