FDA.reportPublic FDA data

URiSCAN 10 SGL strip

Primary DI
08806125680217
Brand
URiSCAN 10 SGL strip
Company
YD Diagnostics CORP.
Model
U774
Device description
Urinalysis dip and read strips for visual and URiSCAN urine analyzer.Test for Leucocytes, Nitrite, Urobilinogen, Glucose, pH, Blood, SG(Specific Gravity), Ketones(Acetoacetic Acid), Bilirubin and Protein in urine.
Published
2016-12-21
Public version status
Update
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-Quant.)
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.)
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
JRERefractometer For Clinical Use
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
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
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1
JRERefractometer For Clinical UseClinical Chemistry1
LJXTest, Urine LeukocyteHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952307000BIOSCANBiosys Laboratories, Inc.1995-09-05JIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806125680217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806125680217088061256802178806125680217

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, kit, colorimetric dipstick, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick (strip) method. This test is 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].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687769737
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806125630229OcculTech Fecal Occult Blood Rapid TestIM706-100M2019-08-13
08806125680019URiSCAN 10 SGL stripU3912016-08-05
08806125680033URiSCAN 2 GP stripU2012016-09-01
08806125680064URiSCAN 6 L stripU2512016-09-01
08806125680224URiSCAN 2 ACR stripU6432016-08-05
08806125680231URiSCAN 10 ACR stripU6212016-08-05
08806125680279UCARE 11 StickP4112017-07-28
08806125680286UCARE 11 StickP4122017-07-28
08806125680071URiSCAN 1 Ketones stripU1512019-11-13
08806125680156URiSCAN 1 Glucose stripU1912019-11-13
08806125619033URiSCAN OptimaOptima2016-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JMT2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JJB2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JRE2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIR2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIO2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.CEN2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.LJX2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.CDM2025-09-18
08806141303497One+Step 10ADFI CO.,LTDJIR2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJIN2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJJB2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJRE2023-10-16
08806141303497One+Step 10ADFI CO.,LTDCDM2023-10-16
08806141303497One+Step 10ADFI CO.,LTDCEN2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJMT2023-10-16
08806141303480One+Step UTIDFI CO.,LTDCEN2023-10-14
08806141303480One+Step UTIDFI CO.,LTDJMT2023-10-14
00860010249000Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
00860010249017Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
00860010249024Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJRE2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDLJX2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDCEN2020-09-22
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08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJJB2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIL2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIR2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIO2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIN2020-09-22