Home GUDID 00304040001516 Henry Schein
Primary DI 00304040001516
Brand Henry Schein
Company HENRY SCHEIN, INC.
Model 9007566
Catalog number 9007566
Device description Urispec + UA Reader
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx 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.) JIP BLOOD, OCCULT, ENZYMATIC METHOD, IN URINE 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) KSL SOLUTION, COPPER SULFATE FOR SPECIFIC GRAVITY DETERMINATIONS 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 JIP Blood, Occult, Enzymatic Method, In Urine Hematology 2 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 KSL Solution, Copper Sulfate For Specific Gravity Determinations Hematology 1 LJX Test, Urine Leukocyte Hematology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00304040001516 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 00304040001516 00304040001516 304040001516 0304040001516
GMDN Terms# Term, Definition table Term Definition Urine analyser IVD, laboratory, semi-automated A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 5 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 012430880 Device count 1 Serial number true Manufacturing date on label true No natural rubber latex 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. 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. JMA 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. JIR 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. JIR 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. JIN 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. KSL 2026-06-03 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 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