UASure II Blood Uric Acid Monitoring System S95046

GUDID 00886338000031

Complete Kit

APEX BIOTECHNOLOGY CORP.

Uric acid IVD, reagent
Primary Device ID00886338000031
NIH Device Record Key5fe440e6-f316-4a53-9054-9054c3c1946d
Commercial Distribution StatusIn Commercial Distribution
Brand NameUASure II Blood Uric Acid Monitoring System
Version Model NumberS95046
Catalog NumberS95046
Company DUNS657608092
Company NameAPEX BIOTECHNOLOGY CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100886338000031 [Primary]

FDA Product Code

LFQAcid, Uric, Acid Reduction Of Ferric Ion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-04
Device Publish Date2021-12-27

Devices Manufactured by APEX BIOTECHNOLOGY CORP.

00886338000031 - UASure II Blood Uric Acid Monitoring System2022-01-04Complete Kit
00886338000031 - UASure II Blood Uric Acid Monitoring System2022-01-04 Complete Kit
00886338000062 - UASure II Blood Uric Acid Test Strips 25s2022-01-04 25s foil packet
00886338000055 - UASure II Uric Acid Control Solution L12022-01-04 Level 1
04713648766530 - THE EDGE Blood Lactate Monitoring System2021-01-26 KIT
04713648766547 - THE EDGE Blood Lactate Test Strip (non-sterile)2021-01-26 25s
04713648766554 - THE EDGE Lactate Control Solution2021-01-26
04713648766493 - ApexBio SteriLance BLOOD LANCET (Sterile)2020-05-25
04713648766462 - UASure Blood Uric Acid Monitoring Meter 2020-05-19 Kit (5s)

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