FDA.reportPublic FDA data

UASure Blood Uric Acid Test Strip

Primary DI
04713648766479
Brand
UASure Blood Uric Acid Test Strip
Company
APEX BIOTECHNOLOGY CORP.
Model
UASure I
Device description
25s
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
LFQAcid, Uric, Acid Reduction Of Ferric Ion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFQAcid, Uric, Acid Reduction Of Ferric IonClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04713648766479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04713648766479047136487664794713648766479

GMDN Terms#

Term, Definition table
TermDefinition
Uric acid monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips, and/or other associated disposable materials intended to be used for the quantitative measurement of uric acid in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It is used to monitor the effectiveness of uric acid control in various disorders (e.g., renal failure, gout, leukaemia), and in patients receiving cytotoxic chemotherapy.

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
04713648766486UASure uric acid control solutionUAsure control solution2020-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00886338000031UASure II Blood Uric Acid Monitoring SystemAPEX BIOTECHNOLOGY CORP.LFQ2021-12-27
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