Home GUDID 20304040037731 CardioChek
Primary DI 20304040037731
Brand CardioChek
Company HENRY SCHEIN, INC.
Model 5700412
Catalog number 5700412
Device description CardioChek 15Lipid/15Glucose
Published 2017-01-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name LBR LDL & VLDL PRECIPITATION, HDL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20304040037731 Package GS1 15 In Commercial Distribution 10304040037734 Primary GS1 0 00304040037737 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20304040037731 20304040037731 10304040037734 10304040037734 00304040037737 00304040037737 304040037737 0304040037737
GMDN Terms# Term, Definition table Term Definition Multiple lipid analyte IVD, kit, multiple technologies A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to produce a lipid profile, using a number of different technologies on a single analyser. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from sunlight. Special Storage Condition, Specify 0 0 Keep dry. Storage Environment Temperature 20 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 68 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 012430880 Device count 2 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06935740725705 Blood Lipid Analyzer Urit Medical Electronic Co., Ltd. LBR 2026-06-03 06935740725712 Blood Lipid Analyzer Urit Medical Electronic Co., Ltd. LBR 2026-06-03 00682607690053 Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25T Acon Laboratories, Inc. LBR 2026-03-09 00682607690077 Mission Cholesterol Optical Check Device Acon Laboratories, Inc. LBR 2026-03-09 00682607690084 Mission Cholesterol Control Solution Acon Laboratories, Inc. LBR 2026-03-09 00682607690091 Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5T Acon Laboratories, Inc. LBR 2026-03-09 10682607690050 Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25T Acon Laboratories, Inc. LBR 2026-03-09 00682607690060 Mission Cholesterol Meter Acon Laboratories, Inc. LBR 2026-03-09 10682607690081 Mission Cholesterol Control Solution Acon Laboratories, Inc. LBR 2026-03-09 06935740726986 Blood Lipid Test Strip Urit Medical Electronic Co., Ltd. LBR 2024-07-12 00850053916175 IDG/Sanzay IDG/SANZAY Corporation LBR 2024-01-12 10673486001907 Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix TECO DIAGNOSTICS LBR 2023-11-20 10673486001938 Teco Diagnostics HDL Cholesterol Reagent Set TECO DIAGNOSTICS LBR 2023-11-20 10673486001884 Teco Diagnostics HDL Cholesterol Reagent Set TECO DIAGNOSTICS LBR 2023-11-10 10673486001891 Teco Diagnostics Direct HDL Cholesterol Reagent Set TECO DIAGNOSTICS LBR 2023-11-10 00381934753010 Lipid Panel, 15ct., CCPlus Home POLYMER TECHNOLOGY SYSTEMS, INC. LBR 2023-06-20 00381934752013 Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk) POLYMER TECHNOLOGY SYSTEMS, INC. LBR 2023-06-01 00887473000337 STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile SD Biosensor, Inc. LBR 2023-05-10 00887473000344 STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile SD Biosensor, Inc. LBR 2023-05-10 00887473000320 STANDARD™ LipidoCare Analyzer SD Biosensor, Inc. LBR 2023-04-07 00381934747019 Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus Home POLYMER TECHNOLOGY SYSTEMS, INC. LBR 2023-03-25 10381934747016 Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus Home POLYMER TECHNOLOGY SYSTEMS, INC. LBR 2023-03-25 00381934749013 Assy Vial, Lipid Panel Test Strips, 1 ct, CardioChek Plus Home POLYMER TECHNOLOGY SYSTEMS, INC. LBR 2023-03-25 00887473000290 STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile SD Biosensor, Inc. LBR 2023-03-17 00887473000306 STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile SD Biosensor, Inc. LBR 2023-03-17 00887473000283 STANDARD™ LipidoCare Analyzer SD Biosensor, Inc. LBR 2023-03-17 00381934750019 CardioChek Plus Home Self-Test Analyzer POLYMER TECHNOLOGY SYSTEMS, INC. LBR 2022-04-11 14987481164533 L-Type LDL-C Reagent 1 FUJIFILM WAKO PURE CHEMICAL CORPORATION LBR 2021-06-01 14987481164540 L-Type LDL-C Reagent 2 FUJIFILM WAKO PURE CHEMICAL CORPORATION LBR 2021-06-01 04987481164536 L-Type LDL-C Reagent 1 FUJIFILM WAKO PURE CHEMICAL CORPORATION LBR 2021-06-01