ACCUTEST H. Pylori Rapid Test Device (Whole Blood/Serum) *CLIA-Waived* - ACCUTEST H. Pylori Rapid Test Device (Whole - JANT PHARMACAL CORPORATION

Duns Number:797393659

Device Description: ACCUTEST H. Pylori Rapid Test Device (Whole Blood/Serum) *CLIA-Waived*

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More Product Details

Catalog Number

-

Brand Name

ACCUTEST H. Pylori Rapid Test Device (Whole Blood/Serum) *CLIA-Waived*

Version/Model Number

ID392

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

09347972-ec7c-4b55-826d-166fbae0ab39

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JANT PHARMACAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 3