Home GUDID 08806141303497 One+Step 10A
Primary DI 08806141303497
Brand One+Step 10A
Company DFI CO.,LTD
Model 30D4
Device description One device is included 100 test strips
Published 2023-10-16
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 Code Name CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) JIN Nitroprusside, Ketones (Urinary, Non-Quant.) JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) 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 JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry 1 JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry 1 JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry 1 JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) 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 08806141303497 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08806141303497 08806141303497 8806141303497
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 Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 688779180 Device count 1 Premarket exempt true Kit true Lot or batch true Manufacturing date on label 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 00682607815098 ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM Acon Laboratories, Inc. JIN 2026-07-30 00682607815104 ON CALL® SURE GK BLOOD GLUCOSE & KETONE METER Acon Laboratories, Inc. JIN 2026-07-30 00682607815111 ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM Acon Laboratories, Inc. JIN 2026-07-30 00682607815272 ON CALL® SURE KETONE CONTROL SOLUTION Acon Laboratories, Inc. JIN 2026-07-30 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. JJB 2026-06-26 06935740751568 Fully-Automated Urine Chemistry Analyzer Urit Medical Electronic Co., Ltd. CDM 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. JIN 2026-06-26 06935740751568 Fully-Automated Urine Chemistry Analyzer Urit Medical Electronic Co., Ltd. JIR 2026-06-26 06935740751568 Fully-Automated Urine Chemistry Analyzer Urit Medical Electronic Co., Ltd. JMA 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. LJX 2026-06-26 06935740751568 Fully-Automated Urine Chemistry Analyzer Urit Medical Electronic Co., Ltd. JRE 2026-06-26 06935740751575 Urine Chemistry Strips Urit Medical Electronic Co., Ltd. JRE 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. JIN 2026-06-26 06935740751575 Urine Chemistry Strips Urit Medical Electronic Co., Ltd. JIR 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. JMA 2026-06-26 06935740751575 Urine Chemistry Strips Urit Medical Electronic Co., Ltd. JMT 2026-06-26 06972164410022 LOOKEE® AscleTrack™ Urine Microalbumin (MAU) Test Strip Kunming Lianen Biotechnology Co., LTD JIR 2026-06-26 06935740751773 Urine Strips Urit Medical Electronic Co., Ltd. JMT 2026-06-03 06935740751773 Urine Strips Urit Medical Electronic Co., Ltd. JMA 2026-06-03 06935740751773 Urine Strips Urit Medical Electronic Co., Ltd. JJB 2026-06-03 06935740751773 Urine Strips Urit Medical Electronic Co., Ltd. JIR 2026-06-03 06935740751773 Urine Strips Urit Medical Electronic Co., Ltd. JIN 2026-06-03