Home GUDID 00304040002575 Henry Schein
Primary DI 00304040002575
Brand Henry Schein
Company HENRY SCHEIN, INC.
Model 9004994
Catalog number 9004994
Device description Urispec 10SG Urine Strip
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name CDM DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) CEN DYE-INDICATOR, PH (URINARY, NON-QUANT.) JIL METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) JIN NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) JIO BLOOD, OCCULT, COLORIMETRIC, IN URINE JJB AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) JJR ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) JMT DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) JRE REFRACTOMETER FOR CLINICAL USE LJX TEST, URINE LEUKOCYTE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry 1 CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry 1 JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry 2 JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry 1 JIO Blood, Occult, Colorimetric, In Urine Hematology 2 JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry 1 JJR Electrolyte Controls (Assayed And Unassayed) Clinical Chemistry 1 JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry 1 JRE Refractometer For Clinical Use Clinical Chemistry 1 LJX Test, Urine Leukocyte Hematology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10304040002572 Package GS1 24 In Commercial Distribution 00304040002575 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10304040002572 10304040002572 00304040002575 00304040002575 304040002575 0304040002575
GMDN Terms# Term, Definition table Term Definition Multiple urine analyte IVD, kit, rapid colorimetric, clinical A 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 Type Low High Condition Special Storage Condition, Specify 0 0 Store out of direct sunlight. Open bottles should be used within 3 months after first openning. Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 012430880 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860015091604 KetoBM KETOBM USA LLC JIN 2026-07-14 00860015091628 KetoBM KETOBM USA LLC JIN 2026-07-14 06935740751568 Fully-Automated Urine Chemistry Analyzer Urit Medical Electronic Co., Ltd. JRE 2026-06-26 06935740751568 Fully-Automated Urine Chemistry Analyzer Urit Medical Electronic Co., Ltd. LJX 2026-06-26 06935740751568 Fully-Automated Urine Chemistry Analyzer Urit Medical Electronic Co., Ltd. JMT 2026-06-26 06935740751568 Fully-Automated Urine Chemistry Analyzer Urit Medical Electronic Co., Ltd. JJB 2026-06-26 06935740751568 Fully-Automated Urine Chemistry Analyzer Urit Medical Electronic Co., Ltd. JIO 2026-06-26 06935740751568 Fully-Automated Urine Chemistry Analyzer Urit Medical Electronic Co., Ltd. JIN 2026-06-26 06935740751568 Fully-Automated Urine Chemistry Analyzer Urit Medical Electronic Co., Ltd. JIL 2026-06-26 06935740751568 Fully-Automated Urine Chemistry Analyzer Urit Medical Electronic Co., Ltd. CEN 2026-06-26 06935740751568 Fully-Automated Urine Chemistry Analyzer Urit Medical Electronic Co., Ltd. CDM 2026-06-26 06935740751575 Urine Chemistry Strips Urit Medical Electronic Co., Ltd. JIN 2026-06-26 06935740751575 Urine Chemistry Strips Urit Medical Electronic Co., Ltd. JIO 2026-06-26 06935740751575 Urine Chemistry Strips Urit Medical Electronic Co., Ltd. CDM 2026-06-26 06935740751575 Urine Chemistry Strips Urit Medical Electronic Co., Ltd. CEN 2026-06-26 06935740751575 Urine Chemistry Strips Urit Medical Electronic Co., Ltd. JIL 2026-06-26 06935740751575 Urine Chemistry Strips Urit Medical Electronic Co., Ltd. JJB 2026-06-26 06935740751575 Urine Chemistry Strips Urit Medical Electronic Co., Ltd. LJX 2026-06-26 06935740751575 Urine Chemistry Strips Urit Medical Electronic Co., Ltd. JMT 2026-06-26 06935740751575 Urine Chemistry Strips Urit Medical Electronic Co., Ltd. JRE 2026-06-26 06935740751773 Urine Strips Urit Medical Electronic Co., Ltd. JMT 2026-06-03 06935740751773 Urine Strips Urit Medical Electronic Co., Ltd. JJB 2026-06-03 06935740751773 Urine Strips Urit Medical Electronic Co., Ltd. JIO 2026-06-03 06935740751773 Urine Strips Urit Medical Electronic Co., Ltd. JIN 2026-06-03 06935740751773 Urine Strips Urit Medical Electronic Co., Ltd. CEN 2026-06-03 06935740751773 Urine Strips Urit Medical Electronic Co., Ltd. LJX 2026-06-03 06935740751773 Urine Strips Urit Medical Electronic Co., Ltd. CDM 2026-06-03 06935740751773 Urine Strips Urit Medical Electronic Co., Ltd. JIL 2026-06-03 06935740751780 URINE REAGENT STRIPS Urit Medical Electronic Co., Ltd. LJX 2026-06-03 06935740751780 URINE REAGENT STRIPS Urit Medical Electronic Co., Ltd. JMT 2026-06-03
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