INSTANT-VIEW H. pylori Rapid Test - INSTANT-VIEW H. pylori Rapid Test - ALFA SCIENTIFIC DESIGNS, INC.

Duns Number:176391167

Device Description: INSTANT-VIEW H. pylori Rapid Test

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More Product Details

Catalog Number

-

Brand Name

INSTANT-VIEW H. pylori Rapid Test

Version/Model Number

05-9475

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

3ebdee5c-446c-4746-b59d-f2a2bca6f342

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALFA SCIENTIFIC DESIGNS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 10