Duns Number:878263359
Device Description: Abbott RealTime CMV m2000 System Combined Application CD-ROM
Catalog Number
09N21-002
Brand Name
RealTime
Version/Model Number
09N21-002
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
P160044
Product Code
PAB
Product Code Name
Cytomegalovirus (cmv) dna quantitative assay
Public Device Record Key
0604507e-5d98-4949-8faa-f27fe0f3adf4
Public Version Date
March 22, 2022
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 |