FDA.reportPublic FDA data

UASure II Blood Uric Acid Test Strips 25s

Primary DI
00886338000048
Brand
UASure II Blood Uric Acid Test Strips 25s
Company
APEX BIOTECHNOLOGY CORP.
Model
S5640997
Catalog number
S5640997
Device description
25s foil packet
Published
2021-12-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PTCUric Acid Test System For At Home Prescription Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTCUric Acid Test System For At Home Prescription UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886338000048PrimaryGS10
00886338000062Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886338000048008863380000488863380000480886338000048
00886338000062008863380000628863380000620886338000062

GMDN Terms#

Term, Definition table
TermDefinition
Uric acid IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of uric acid in a clinical specimen.

Regulatory Flags#

DUNS number
657608092
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04713648766486UASure uric acid control solutionUAsure control solution2020-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816042015250FORAFORA CARE INC.PTC2024-09-23
80816042015256FORAFORA CARE INC.PTC2024-09-23
00886338000031UASure II Blood Uric Acid Monitoring SystemAPEX BIOTECHNOLOGY CORP.PTC2021-12-27