Duns Number:878263359
Device Description: Abbott RealTime CMV Amplification Reagent Kit
Catalog Number
09N21-090
Brand Name
RealTime
Version/Model Number
09N21-090
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P160044,P160044,P160044
Product Code
PAB
Product Code Name
Cytomegalovirus (cmv) dna quantitative assay
Public Device Record Key
71e12d7d-2389-44d4-bc6b-ab630ba0d719
Public Version Date
January 31, 2020
Public Version Number
4
DI Record Publish Date
June 06, 2017
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 | 339 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 36 |