FDA.reportPublic FDA data

Aspartate Aminotransferase Test Strip

Primary DI
06935740751476
Brand
Aspartate Aminotransferase Test Strip
Company
Urit Medical Electronic Co., Ltd.
Model
PS 92.25 strips/vial ×4/box
Published
2026-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CISHydrazone Colorimetry, Ast/Sgot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CISHydrazone Colorimetry, Ast/SgotClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06935740751476PrimaryGS10
86935740751472Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06935740751476069357407514766935740751476
8693574075147286935740751472

GMDN Terms#

Term, Definition table
TermDefinition
Total aspartate aminotransferase (AST) 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 total aspartate aminotransferase (AST) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
653742429
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06935740751483Alanine Aminotransferase Test StripPL 92B,25 strips/vial ×4/box2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751452Aspartate Aminotransferase Test StripUrit Medical Electronic Co., Ltd.CIS2026-06-01
06935740751469Aspartate Aminotransferase Test StripUrit Medical Electronic Co., Ltd.CIS2026-06-01
05055273200409ASPARTATE AMINOTRANSFERASE (AST)RANDOX LABORATORIES LIMITEDCIS2019-06-03
05055273200447ASPARTATE AMINOTRANSFERASE (AST)RANDOX LABORATORIES LIMITEDCIS2019-06-03