Duns Number:790524891
Device Description: ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-quantitative ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-quantitative detection of IgG antibodies to rubella in human serum to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child bearing age.
Catalog Number
720-360
Brand Name
Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit
Version/Model Number
720-360
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
K981729
Product Code
LFX
Product Code Name
Enzyme Linked Immunoabsorbent Assay, Rubella
Public Device Record Key
8ca2657f-64ca-404a-9b77-798d371e8f8f
Public Version Date
June 04, 2021
Public Version Number
2
DI Record Publish Date
July 27, 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 |