Duns Number:075150847
Device Description: The Beta-2 Microglobulin ELISA is intended for the quantitative determination of ß2-microg The Beta-2 Microglobulin ELISA is intended for the quantitative determination of ß2-microglobulin in human serum.
Catalog Number
EIA-1789
Brand Name
Beta-2 Microglobulin ELISA
Version/Model Number
EIA-1789
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
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
K001022
Product Code
JZG
Product Code Name
System, test, beta-2-microglobulin immunological
Public Device Record Key
7bc8810e-c9b1-4fd9-9b99-43e63cba7e5d
Public Version Date
October 10, 2022
Public Version Number
3
DI Record Publish Date
June 10, 2019
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |