UASure Blood Uric Acid Monitoring Meter

GUDID 04713648766462

Kit (5s)

APEX BIOTECHNOLOGY CORP.

Uric acid monitoring system IVD, home-use Uric acid monitoring system IVD, home-use Uric acid monitoring system IVD, home-use
Primary Device ID04713648766462
NIH Device Record Key906a27df-d434-4ea6-8a96-b5d4b56b17d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameUASure Blood Uric Acid Monitoring Meter
Version Model NumberUASure Meter
Company DUNS657608092
Company NameAPEX BIOTECHNOLOGY CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
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
GS104713648766462 [Primary]
GS104713648766462 [Primary]
GS104713648766462 [Primary]

FDA Product Code

LFQAcid, Uric, Acid Reduction Of Ferric Ion
LFQAcid, Uric, Acid Reduction Of Ferric Ion
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 Date2020-05-19
Device Publish Date2020-05-11

Devices Manufactured by APEX BIOTECHNOLOGY CORP.

04713648766493 - ApexBio SteriLance BLOOD LANCET (Sterile)2020-05-25
04713648766462 - UASure Blood Uric Acid Monitoring Meter 2020-05-19Kit (5s)
04713648766462 - UASure Blood Uric Acid Monitoring Meter 2020-05-19 Kit (5s)
04713648766479 - UASure Blood Uric Acid Test Strip2020-05-19 25s
04713648766486 - UASure uric acid control solution2020-05-19

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