Duns Number:790524891
Device Description: ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytomegalovirus ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytomegalovirus (CMV) as an aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals.
Catalog Number
720-320
Brand Name
Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit
Version/Model Number
720-320
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K981163
Product Code
LFZ
Product Code Name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Public Device Record Key
a5bb5d21-fe85-4a9c-8420-e78a53158c5c
Public Version Date
June 04, 2021
Public Version Number
2
DI Record Publish Date
June 03, 2020
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |