BioSign Flu A+B Nasal Wash/Aspirate Kit - BioSign Flu A+B Nasopharyngeal Wash/Aspirate Kit, - PRINCETON BIOMEDITECH CORPORATION

Duns Number:362917692

Device Description: BioSign Flu A+B Nasopharyngeal Wash/Aspirate Kit, 50 pipettes

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More Product Details

Catalog Number

BSP-510AS-07

Brand Name

BioSign Flu A+B Nasal Wash/Aspirate Kit

Version/Model Number

BSP-510AS-07

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)

-

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

GNK

Product Code Name

Antisera, Cf, Echovirus 1-34

Device Record Status

Public Device Record Key

7dfa13e2-c8a7-44c4-a611-eb6fae0174c6

Public Version Date

January 22, 2021

Public Version Number

2

DI Record Publish Date

July 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRINCETON BIOMEDITECH CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 92
U Unclassified 2