FDA.reportPublic FDA data

UASure uric acid control solution

Primary DI
04713648766486
Brand
UASure uric acid control solution
Company
APEX BIOTECHNOLOGY CORP.
Model
UAsure control solution
Published
2020-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Single use
true

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04713648766486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04713648766486047136487664864713648766486

GMDN Terms#

Term, Definition table
TermDefinition
Uric acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of uric acid in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657608092
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886338000048UASure II Blood Uric Acid Test Strips 25sS5640997S56409972021-12-27
00886338000031UASure II Blood Uric Acid Monitoring SystemS95046S950462021-12-27
04713648766493ApexBio SteriLance BLOOD LANCET (Sterile)lancet2020-05-15
00886338000062UASure II Blood Uric Acid Test Strips 25sS5640997S56409972021-12-27
00886338000055UASure II Uric Acid Control Solution L1S5800397S58003972021-12-27
04713648766530THE EDGE Blood Lactate Monitoring SystemThe EDGE meter2021-01-18
04713648766547THE EDGE Blood Lactate Test Strip (non-sterile)The EDGE test strip2021-01-18
04713648766554THE EDGE Lactate Control SolutionThe EDGE control solution2021-01-18
04713648766462UASure Blood Uric Acid Monitoring Meter UASure Meter2020-05-11
04713648766479UASure Blood Uric Acid Test StripUASure I2020-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLCJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
10758750035380VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-05-20
10758750035076VITROSORTHO CLINICAL DIAGNOSTICSJJX2024-09-18
00021292015091TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00021292015107TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSJJX2022-08-09
00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
14987481164441uTASWako AFP-L3 Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164458uTASWako AFP-L3 Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164489uTASWako DCP Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164496uTASWako DCP Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
00021292008390TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21
00021292008406TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21