Serim® PyloriTek® Test Kit - The Serim PyloriTek Test Kit detects urease - SERIM RESEARCH CORPORATION

Duns Number:605151018

Device Description: The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the p The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.

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More Product Details

Catalog Number

05140S

Brand Name

Serim® PyloriTek® Test Kit

Version/Model Number

05140S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K953632,K953632,K953632

Product Code Details

Product Code

LYR

Product Code Name

Helicobacter Pylori

Device Record Status

Public Device Record Key

2a6ec87b-2f03-4105-8827-80edde6415ef

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

M1745140S2

Quantity per Package

1

Contains DI Package

M1745140S1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit