Duns Number:008254708
Device Description: The Access BNP test is intended for use with the Beckman Coulter Access Family of Immunoas The Access BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications:• as an aid in the diagnosis of congestive heart failure (also referred to as heart failure)• as an aid in the assessment of severity of congestive heart failure • for the risk stratification of patients with acute coronary syndromes• for the risk stratification of patients with heart failure
Catalog Number
98200
Brand Name
Access BNP
Version/Model Number
98200
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
-
Product Code
NBC
Product Code Name
Test, Natriuretic Peptide
Public Device Record Key
924c125a-f9b2-4892-bb58-d272c21239d5
Public Version Date
August 26, 2021
Public Version Number
1
DI Record Publish Date
August 18, 2021
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 | 319 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 503 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 1 |