FDA.reportPublic FDA data

UASure II Blood Uric Acid Monitoring System

Primary DI
00886338000031
Brand
UASure II Blood Uric Acid Monitoring System
Company
APEX BIOTECHNOLOGY CORP.
Model
S95046
Catalog number
S95046
Device description
Complete Kit
Published
2021-12-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LFQAcid, Uric, Acid Reduction Of Ferric Ion
PTCUric Acid Test System For At Home Prescription Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFQAcid, Uric, Acid Reduction Of Ferric IonClinical Chemistry1
PTCUric Acid Test System For At Home Prescription UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886338000031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886338000031008863380000318863380000310886338000031

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657608092
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
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
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
00816042014475FORAFORA CARE INC.LFQ2023-10-31
00850014861353HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX)Hearts Bio, Inc.LFQ2023-08-08
00816042014116FORAFORA CARE INC.LFQ2023-06-26
00816042014192FORAFORA CARE INC.LFQ2023-06-26
00816042014109FORAFORA CARE INC.LFQ2023-06-26
80816042014112FORAFORA CARE INC.LFQ2023-06-26
00816042014185FORAFORA CARE INC.LFQ2023-06-26
80816042014198FORAFORA CARE INC.LFQ2023-06-26
06971404131611Uric Acid Control solution(level 1)e-Linkcare Meditech Co., LtdLFQ2022-05-17
06971404131628Uric Acid Control solution(level 2)e-Linkcare Meditech Co., LtdLFQ2022-05-17
00886338000048UASure II Blood Uric Acid Test Strips 25sAPEX BIOTECHNOLOGY CORP.PTC2021-12-27
00886338000062UASure II Blood Uric Acid Test Strips 25sAPEX BIOTECHNOLOGY CORP.LFQ2021-12-27
16971404130949Blood Uric Acid Test Stripse-Linkcare Meditech Co., LtdLFQ2021-12-17
06971404130928Blood Uric Acid Monitoring Systeme-Linkcare Meditech Co., LtdLFQ2021-12-17
16971404130925Blood Uric Acid Monitoring Systeme-Linkcare Meditech Co., LtdLFQ2021-12-17
26971404130946Blood Uric Acid Test Stripse-Linkcare Meditech Co., LtdLFQ2021-12-17
04713648766462UASure Blood Uric Acid Monitoring Meter APEX BIOTECHNOLOGY CORP.LFQ2020-05-11
04713648766479UASure Blood Uric Acid Test StripAPEX BIOTECHNOLOGY CORP.LFQ2020-05-11