Access BNP - The Access BNP test is intended for use with the - Beckman Coulter, Inc.

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

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More Product Details

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

Product Characteristics

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 Details

Product Code

NBC

Product Code Name

Test, Natriuretic Peptide

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BECKMAN COULTER, INC." Characteristics
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