BD Veritor System Flu Control Swab set - 10 ea. Flu A+/B- Control Swabs, 10 ea. Flu A-/B+ - BECTON, DICKINSON AND COMPANY

Duns Number:122561087

Device Description: 10 ea. Flu A+/B- Control Swabs, 10 ea. Flu A-/B+ Control Swabs

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More Product Details

Catalog Number

256051

Brand Name

BD Veritor System Flu Control Swab set

Version/Model Number

256051

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

JJX

Product Code Name

Single (specified) analyte controls (assayed and unassayed)

Device Record Status

Public Device Record Key

6d76f961-3dd1-46b0-a777-8124e7040b4d

Public Version Date

June 25, 2018

Public Version Number

1

DI Record Publish Date

May 25, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BECTON, DICKINSON AND COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 611
2 A medical device with a moderate to high risk that requires special controls. 614
3 A medical device with high risk that requires premarket approval 36
U Unclassified 4