Stix - Three UTI tests - Get Stix Inc.

Duns Number:117116737

Device Description: Three UTI tests

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More Product Details

Catalog Number

-

Brand Name

Stix

Version/Model Number

1

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K063295,K063295

Product Code Details

Product Code

LJX

Product Code Name

TEST, URINE LEUKOCYTE

Device Record Status

Public Device Record Key

b8388dcc-cdde-4603-a4bb-47e3142ccc03

Public Version Date

May 18, 2021

Public Version Number

3

DI Record Publish Date

October 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GET STIX INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3