Duns Number:276816717
Device Description: VIDAS ® CMV IgM (CMVM) assay is an automated qualitative IA intended for use on VIDAS fami VIDAS ® CMV IgM (CMVM) assay is an automated qualitative IA intended for use on VIDAS family instrument for detection of anti - CMV IgM antibodies in human serum.
Catalog Number
-
Brand Name
VIDAS® CMV IgM
Version/Model Number
30205-01
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
K933549
Product Code
LKQ
Product Code Name
Antibody Igm,If, Cytomegalovirus Virus
Public Device Record Key
59932df4-96d2-4915-bab5-2850f38a5551
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 2016
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |