Duns Number:388240673
Device Description: Quantitative determination of ß2-microglobulin in human serum, plasma and urine on BN Syst Quantitative determination of ß2-microglobulin in human serum, plasma and urine on BN Systems
Catalog Number
OQWU21
Brand Name
N Latex ß2-Microglobulin
Version/Model Number
10446162
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K002731
Product Code
JZG
Product Code Name
SYSTEM, TEST, BETA-2-MICROGLOBULIN IMMUNOLOGICAL
Public Device Record Key
7175eb56-67d6-4132-8259-fb0d835f1100
Public Version Date
October 10, 2022
Public Version Number
6
DI Record Publish Date
September 24, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |