Duns Number:388240673
Device Description: Determination of Rheumatoid factors (RF) in human serum and plasma on the BN II and BN Pro Determination of Rheumatoid factors (RF) in human serum and plasma on the BN II and BN ProSpec® Systems
Catalog Number
OPCE03
Brand Name
N Latex RF Kit
Version/Model Number
10445991
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
K071247
Product Code
DHR
Product Code Name
SYSTEM, TEST, RHEUMATOID FACTOR
Public Device Record Key
2872faea-27f4-44bd-b90e-c99be156819a
Public Version Date
November 18, 2021
Public Version Number
5
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 |