Triage - Triage BNP Test - QUIDEL CARDIOVASCULAR INC.

Duns Number:080890141

Device Description: Triage BNP Test

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More Product Details

Catalog Number

98000XR

Brand Name

Triage

Version/Model Number

98000XR

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

Yes

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

6a5d105d-0b83-404c-9cb9-f49dc47e577c

Public Version Date

April 02, 2020

Public Version Number

2

DI Record Publish Date

November 01, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QUIDEL CARDIOVASCULAR INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 20
2 A medical device with a moderate to high risk that requires special controls. 20