Status™ H. pylori card - Status™ H. pylori card; 25 Test kit - PRINCETON BIOMEDITECH CORPORATION

Duns Number:362917692

Device Description: Status™ H. pylori card; 25 Test kit

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More Product Details

Catalog Number

-

Brand Name

Status™ H. pylori card

Version/Model Number

BSP-406WB-25-02

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

LYR

Product Code Name

Helicobacter Pylori

Device Record Status

Public Device Record Key

89fa3a56-fd4f-46b9-8c93-d40e4f949420

Public Version Date

August 12, 2021

Public Version Number

1

DI Record Publish Date

August 04, 2021

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