FDA.reportPublic FDA data

Alanine Aminotransferase Test Strip

Primary DI
06935740751483
Brand
Alanine Aminotransferase Test Strip
Company
Urit Medical Electronic Co., Ltd.
Model
PL 92B,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
CKDHydrazone Colorimetry, Alt/Sgpt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CKDHydrazone Colorimetry, Alt/SgptClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06935740751483PrimaryGS10
86935740751489Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06935740751483069357407514836935740751483
8693574075148986935740751489

GMDN Terms#

Term, Definition table
TermDefinition
Alanine aminotransferase (ALT) 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 alanine aminotransferase (ALT) in a clinical specimen.

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
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
06935740751490Alanine Aminotransferase Test StripPL 92A,25 strips/vial ×4/box2026-06-01
06935740751506Alanine Aminotransferase Test StripPL 92,25 strips/vial ×4/box2026-06-01
06935740751513Hemoglobin Control SolutionHQ 03,2 bottles /box (Level 1:1mL /bottle,Level 2:2026-06-01
06935740751520Hemoglobin Control SolutionHQ 02,2 bottles /box (Level 1:1mL /bottle,Level 2:2026-06-01
06935740750608Urine Reagent StripsURIT 11FA,100 pcs/tube2026-04-16
06935740750615Urine Reagent StripsURIT 12FA ,100 pcs/tube2026-04-16
06935740750622Detergent for Automatic Urine AnalyzerURIT D22,1L2026-04-16
06935740750639Detergent for Automatic Urine AnalyzerURIT D21N,500mL2026-04-16
06935740750646Detergent for Automatic Urine AnalyzerURIT D21,5L2026-04-16
06935740750653Calibrator Solution For Urine AnalyzerURIT YC 2ST,C-SG and C-TUR(C-SG:2×8mL, C-TUR:2×8mL2026-04-16
06935740750660Calibrator Solution For Urine AnalyzerURIT YC 2ST,C-SG(2×8mL)2026-04-16
06935740750677Calibrator Solution For Urine AnalyzerURIT YC 2ST,C-TUR(2×8mL)2026-04-16
06935740750684Quality Control Solution For Urine AnalyzerURIT YQ 3STC2026-04-16
06935740750691Quality Control Solution For Urine AnalyzerURIT YQ 3STC,COL(Red:1×8mL,Yellow:1×8mL,Green:1×8m2026-04-16
06935740750707Quality Control Solution For Urine AnalyzerURIT YQ 3STC,TUR(Level 1:1×8mL,Level 2:1×8mL)2026-04-16
06935740750714Quality Control Solution For Urine AnalyzerURIT YQ 3STC,SG(Level 1:1×8mL,Level 2:1×8mL,Level 2026-04-16
06935740750721Urinalysis ControlUQ-14,NO.I:8mL,NO.II:8mL,NO.III:8mL2026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751490Alanine Aminotransferase Test StripUrit Medical Electronic Co., Ltd.CKD2026-06-01
06935740751506Alanine Aminotransferase Test StripUrit Medical Electronic Co., Ltd.CKD2026-06-01
10673486013979Teco Diagnostics ALT (SGPT) Reagent Set (Colorimetric, Endpoint Method)TECO DIAGNOSTICSCKD2026-01-19