Home GUDID 03607360041161 HYDRAGEL 7 LDL/HDL CHOL DIRECT
Primary DI 03607360041161
Brand HYDRAGEL 7 LDL/HDL CHOL DIRECT
Company SEBIA
Model 4116
Catalog number 4116
Published 2022-12-12
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name JHO Electrophoretic Separation, Lipoproteins
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JHO Electrophoretic Separation, Lipoproteins Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03607360041161 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03607360041161 03607360041161 3607360041161
GMDN Terms# Term, Definition table Term Definition Protein electrophoresis IVD, kit, electrophoresis A collection of reagents and other associated materials intended to be used for determining the qualitative and/or quantitative separation of proteins in a clinical specimen, using an electrophoresis method.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 DO NOT FREEZE FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 276801933 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 03607360043165 ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 & 9 IF MAXI-KIT (DYNAMIC MASK) 4316 4316 2026-01-09 03607360043189 ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 BENCE JONES MAXI-KIT(DYNAMIC MASK) 4318 4318 2026-01-09 03607360043875 HYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK) 4387 4387 2026-01-09 03607360048160 ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 IF MAXI-KIT (STANDARD MASK) 4816 4816 2026-01-09 03607360048177 ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 IF MAXI-KIT (STANDARD MASK) 4817 4817 2026-01-09 03607360048184 ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 BENCE JONESMAXI-KIT(STANDARD MASK) 4818 4818 2026-01-09 03607360048191 ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT(STANDARD MASK) 4819 4819 2026-01-09 03607360043196 ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT (DYNAMIC MASK) 4319 4319 2026-01-08 03607360043868 HYDRAGEL 4 IF MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK) 4386 4386 2026-01-08 03607360043882 HYDRAGEL 9 BENCE JONES MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK) 4388 4388 2026-01-08 03607360043899 HYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK) 4389 4389 2026-01-08 03607360048863 HYDRAGEL 4 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK) 4886 4886 2026-01-08 03607360048870 HYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK) 4887 4887 2026-01-08 03607360048887 HYDRAGEL 9 BENCE JONES MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK) 4888 4888 2026-01-08 03607360048894 HYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK) 4889 4889 2026-01-08 03607360012444 CAPILLARYS 3 DBS 1244 1244 2024-04-30 03607360025062 CAPI 3 NEONAT Hb 2506 2506 2024-04-30 03607360025635 CAPI 3 NEONAT HEMOLYSING SOLUTION 2563 2563 2024-04-30 03607360025789 CAPILLARYS 3 DBS MICROPLATES 2578 2578 2024-04-30 03607360047576 CAPI 3 NEONAT Hb AF Control 4757 4757 2024-04-30
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 03607360030073 HYDRAGEL LIPO + Lp(a) K20 SEBIA JHO 2022-12-12 03607360041048 HYDRAGEL 7 LIPO + Lp(a) SEBIA JHO 2022-12-12 03607360041147 HYDRAGEL 7 LIPOPROTEIN(E) SEBIA JHO 2022-12-12 03607360041246 HYDRAGEL 15 LIPO + Lp(a) SEBIA JHO 2022-12-12 03607360041352 HYDRAGEL 15 LDL/HDL CHOL DIRECT SEBIA JHO 2022-12-12 03607360041390 HYDRAGEL 30 LDL/HDL CHOL DIRECT SEBIA JHO 2022-12-12 03607360041444 HYDRAGEL 30 LIPO + Lp(a) SEBIA JHO 2022-12-12 00896863002318 Liposure Serum Lipoprotein Control Level 1 4x0.5mL QUANTIMETRIX CORPORATION JHO 2018-09-26 00896863002325 Lipoprint System Buffer 4x16.5g QUANTIMETRIX CORPORATION JHO 2018-09-26 00896863002332 Lipoprint LDL Subfractions Kit 4x25 tests QUANTIMETRIX CORPORATION JHO 2018-09-26 M52539000 Titan III Lipo (60 x 76 mm) HELENA LABORATORIES CORPORATION JHO 2017-03-17 M52550450 Coolant Sponges (10/pkg) HELENA LABORATORIES CORPORATION JHO 2017-03-17 M52553220 Lipoprotein Stain (1 x 2.8 g Powder) HELENA LABORATORIES CORPORATION JHO 2017-03-17 M5255519190 SPIFE Vis Cholesterol Kit HELENA LABORATORIES CORPORATION JHO 2017-03-17 M5255519410 SPIFE Vis Cholesterol Reagent Kit HELENA LABORATORIES CORPORATION JHO 2017-03-17 M5255519910 SPIFE Lipoprotein Gel Kit HELENA LABORATORIES CORPORATION JHO 2017-03-17 M5255520030 QUICKGEL Cholesterol Gel Kit HELENA LABORATORIES CORPORATION JHO 2017-03-17 M5255523630 QUICKGEL Lipoprotein Gel Kit HELENA LABORATORIES CORPORATION JHO 2017-03-17 M5255526080 SPIFE Lipoprotein Gel Kit HELENA LABORATORIES CORPORATION JHO 2017-03-17 M5255526140 SPIFE Vis Cholesterol Kit HELENA LABORATORIES CORPORATION JHO 2017-03-17 05391516743938 Trinity Biotech CLARK LABORATORIES, INC. JHO 2016-09-23