Duns Number:276816717
Device Description: Argene CINAKit is intended for use as an aid in the diagnosis of Cytomegalovirus (CMV) inf Argene CINAKit is intended for use as an aid in the diagnosis of Cytomegalovirus (CMV) infection by the qualitative detection of CMV pp65 antigen by indirect immunofluore scence
Catalog Number
-
Brand Name
ARGENE® CINAkit HCMV ppUL83 US
Version/Model Number
19-0028US
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 24, 2018
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
K982311
Product Code
GQH
Product Code Name
Antigen, Cf (Including Cf Control), Cytomegalovirus
Public Device Record Key
8eeb3922-77fe-45d3-85de-a8f14e50d652
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
October 17, 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 |