Duns Number:790524891
Device Description: ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to measles viru ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to measles virus as an aid in the assessment of the patient's immunological response to measles and to determine the immune status of individuals, and as an aid in the diagnosis of measles infection.
Catalog Number
720-520
Brand Name
Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit
Version/Model Number
720-520
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
K974552
Product Code
LJB
Product Code Name
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Public Device Record Key
023e576f-4eaa-4faf-89d8-6a832e3849e3
Public Version Date
June 04, 2021
Public Version Number
2
DI Record Publish Date
May 20, 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 |