Duns Number:388240673
Device Description: The BN ProSpec® is a system for the quantitative determination of proteins in serum, plasm The BN ProSpec® is a system for the quantitative determination of proteins in serum, plasma, urine and CSF
Catalog Number
OVLI012
Brand Name
BN ProSpec® System
Version/Model Number
10465217
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
K001647
Product Code
JZW
Product Code Name
NEPHELOMETER
Public Device Record Key
99f24eb0-73d1-49ef-a30c-012b83806ed8
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
September 24, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |