FDA.reportPublic FDA data

Urine Reagent Strips

Primary DI
06935740750608
Brand
Urine Reagent Strips
Company
Urit Medical Electronic Co., Ltd.
Model
URIT 11FA,100 pcs/tube
Published
2026-04-16
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
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
CENDye-Indicator, Ph (Urinary, Non-Quantitative)
JFYEnzymatic Method, Creatinine
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
JINNitroprusside, Ketones (Urinary, Non-Quant.)
JIOBlood, Occult, Colorimetric, In Urine
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
JRERefractometer For Clinical Use
KQOAutomated Urinalysis System
LJXTest, Urine Leukocyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)Clinical Chemistry1
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical Chemistry1
JFYEnzymatic Method, CreatinineClinical Chemistry2
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical Chemistry2
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1
JIOBlood, Occult, Colorimetric, In UrineHematology2
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)Clinical Chemistry1
JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)Clinical Chemistry1
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1
JRERefractometer For Clinical UseClinical Chemistry1
KQOAutomated Urinalysis SystemClinical Chemistry1
LJXTest, Urine LeukocyteHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232317000UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent StripsUrit Medical Electronic Co., Ltd.2024-04-26JIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06935740750608PrimaryGS10
86935740750604Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06935740750608069357407506086935740750608
8693574075060486935740750604

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.

Storage And Handling#

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

Regulatory Flags#

DUNS number
653742429
Device count
100
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
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
06935740750738Automatic Urine AnalyzerUC-18002026-04-16
06935740746595MagnifierEX-06 ;1Pc/Box2025-09-22
06935740746601MagnifierEX-06 ;1Pc/Box2025-09-22
06935740726993Hemoglobin Test StripPH 01;25pieces/vial×2/box2024-09-20
06935740733755Automatic Urine AnalyzerUC-18002024-06-14
06935740726986Blood Lipid Test StripPFS 30,10strips/vial×2/box2024-07-12
06935740727006Uric Acid Test StripPA 11,25strips/vial×2/box2024-07-12
06935740727013Uric Acid Test StripPA 16,25strips/vial×2/box2024-07-12

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Primary DI, Brand, Company table
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