FDA.reportPublic FDA data

Uric Acid Test Strip

Primary DI
06935740727006
Brand
Uric Acid Test Strip
Company
Urit Medical Electronic Co., Ltd.
Model
PA 11,25strips/vial×2/box
Published
2024-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JHCAcid, Uric, Uricase (Oxygen Rate)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHCAcid, Uric, Uricase (Oxygen Rate)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06935740727006PrimaryGS10
86935740727002Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06935740727006069357407270066935740727006
8693574072700286935740727002

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
653742429
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06935740725705Blood Lipid AnalyzerPFS-30,1 Set/box2026-06-03
06935740725712Blood Lipid AnalyzerPFS-30A,1 Set/box2026-06-03
06935740730655Uric Acid MeterURIT-10,1 Set/box2026-06-03
06935740730679Uric Acid MeterPA-11,1 Set/box2026-06-03
06935740730716Hemoglobin MeterPH-01,1 Set/box2026-06-03
06935740730723Hemoglobin MeterPH-01A,1 Set/box2026-06-03
06935740751773Urine StripsUrineRS-11-MA2026-06-03
06935740751780URINE REAGENT STRIPSURITEST 11G2026-06-03
06935740751797URINE REAGENT STRIPSURITEST 13G2026-06-03
06935740751803Urine StripsUrineRS-132026-06-03
06935740751810Urine StripsUrineRS-102026-06-03
06935740751827URINE REAGENT STRIPSURITEST 10G2026-06-03
06935740751834Urine StripsUrineRS-112026-06-03
06935740751841Urine AnalyzerHTI CL-50 Plus2026-06-03
06935740751858Urine AnalyzerHTI CL-5002026-06-03
06935740751865URINE ANALYZERURITEST-500B2026-06-03
06935740751872URINE ANALYZERURITEST-502026-06-03
06935740751452Aspartate Aminotransferase Test StripPS 92B,25 strips/vial ×4/box2026-06-01
06935740751469Aspartate Aminotransferase Test StripPS 92A,25 strips/vial ×4/box2026-06-01
06935740751476Aspartate Aminotransferase Test StripPS 92.25 strips/vial ×4/box2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740730655Uric Acid MeterUrit Medical Electronic Co., Ltd.JHC2026-06-03
06935740730679Uric Acid MeterUrit Medical Electronic Co., Ltd.JHC2026-06-03
06935740727013Uric Acid Test StripUrit Medical Electronic Co., Ltd.JHC2024-07-12
06935740727020Uric Acid Test StripUrit Medical Electronic Co., Ltd.JHC2024-07-12
06935740727037Uric Acid Test StripUrit Medical Electronic Co., Ltd.JHC2024-07-12
04712558761116eBuricacidVISGENEER, INC.JHC2023-07-05
04712558761123eBuricacidVISGENEER, INC.JHC2023-07-05