Duns Number:317103745
Device Description: The CMV Primer ASR contains a specific nucleic acid sequence for the amplification of cyto The CMV Primer ASR contains a specific nucleic acid sequence for the amplification of cytomegalovirus (CMV). The CMV Primer ASR is designed to detect a 105 bp region of the MIE gene in the CMV genome. The DNA is synthetically derived.Analyte Specific Reagent. Analytical and performance characteristics are not established.
Catalog Number
1124260
Brand Name
CMV Primer ASR
Version/Model Number
V1
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
-
Product Code
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
932c2ef4-1c10-4b88-8b74-75b7bb99000f
Public Version Date
June 10, 2021
Public Version Number
1
DI Record Publish Date
June 02, 2021
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| 3 | A medical device with high risk that requires premarket approval | 8 |