UASure uric acid control solution

GUDID 04713648766486

APEX BIOTECHNOLOGY CORP.

Uric acid IVD, control Uric acid IVD, control Uric acid IVD, control
Primary Device ID04713648766486
NIH Device Record Keyd8d595a8-d994-49aa-9c64-76baff8ed43e
Commercial Distribution StatusIn Commercial Distribution
Brand NameUASure uric acid control solution
Version Model NumberUAsure control solution
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 Numberfalse
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
GS104713648766486 [Primary]
GS104713648766486 [Primary]
GS104713648766486 [Primary]

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

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 2020-05-19 Kit (5s)
04713648766479 - UASure Blood Uric Acid Test Strip2020-05-19 25s
04713648766486 - UASure uric acid control solution2020-05-19
04713648766486 - UASure uric acid control solution2020-05-19

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