Duns Number:315786293
Device Description: ARCHITECT BNP Reagent Kit
Catalog Number
08K2836
Brand Name
ARCHITECT
Version/Model Number
08K2836
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K060964
Product Code
NBC
Product Code Name
Test, natriuretic peptide
Public Device Record Key
0b07aeda-77ab-48d1-bb80-937fe2762828
Public Version Date
June 22, 2020
Public Version Number
2
DI Record Publish Date
January 21, 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 | 347 |
2 | A medical device with a moderate to high risk that requires special controls. | 185 |
3 | A medical device with high risk that requires premarket approval | 13 |