UASure II Blood Uric Acid Test Strips 25s - 25s foil packet - APEX BIOTECHNOLOGY CORP.

Duns Number:657608092

Device Description: 25s foil packet

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More Product Details

Catalog Number

S5640997

Brand Name

UASure II Blood Uric Acid Test Strips 25s

Version/Model Number

S5640997

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

LFQ

Product Code Name

Acid, Uric, Acid Reduction Of Ferric Ion

Device Record Status

Public Device Record Key

b264b0e7-c24c-47a0-b62c-132048848c8b

Public Version Date

January 04, 2022

Public Version Number

1

DI Record Publish Date

December 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"APEX BIOTECHNOLOGY CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 1