Home GUDID 00848838026768 REMEL
Primary DI 00848838026768
Brand REMEL
Company REMEL, INC.
Model R24250
Catalog number R24250
Device description RIM E. coli O157:H7 Latex 50TST/KT
Published 2022-12-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name GNA Antisera, All Types, Escherichia Coli
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GNA Antisera, All Types, Escherichia Coli Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00848838026768 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 00848838026768 00848838026768 848838026768 0848838026768
GMDN Terms# Term, Definition table Term Definition Escherichia coli antigen IVD, kit, rapid agglutination, clinical A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate within a short period, relative to standard laboratory testing procedures, using a rapid agglutination method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Regulatory Flags# DUNS number 065769564 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 00848838018855 NA CP114-10 2016-09-24 00848838031274 REMEL R40041 R40041 2023-01-03 00842558116709 Spectra™ Candida Agar R01833 2026-02-09 00848838072772 MicroTest M6 R12582 R12582 2022-12-22 00848838074844 MicroTest M4RT R12567 R12567 2022-12-22 00848838075018 MicroTest M6 R12560 R12560 2022-12-22 00848838091827 NA 7115-60 2022-04-21 00848838091742 VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-30 2025-01-16 00848838091834 NA 7116-70 2016-12-09 00848838003158 Strep Selective II Agar R01859 2026-01-16 00848838059865 ^BM^ PK/50 OXIDASE TEST R9055635 2026-01-16 00848838066856 Liquid Amies,Dual Swab PK/50 R723095 2025-06-18 00848838066887 Liquid Stuarts,Single Swab PK/500 R723110 2025-06-18 00848838066894 Liquid Stuarts,Single Swab PK/50 R723115 2025-06-18 00848838066900 Liquid Stuarts,Dual Swab PK/500 R723120 2025-06-18 00848838066917 Liquid Stuarts,Dual Swab PK/50 R723125 2025-06-18 00848838066924 Liquid Stuarts,Wire Shaft Swab PK/100 R723130 2025-06-18 00848838066931 Liquid Stuarts,Wire Shaft PK/50 R723135 2025-06-18 00848838011177 Sensititre Demineralized Water T3339 2023-12-21 00842558105611 ^CE^Liq Stuarts,Dual Swab 36mmPK/500 r9723120 2025-10-02
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10628429001049 Prolex E. coli O157 Latex Test Reagent Kit (50 tests) PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001056 Prolex E. coli O157 Latex Test Reagent Kit (100 tests) PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001100 Prolex E. coli O157 Latex Reagent Control Negative PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001124 Prolex E. coli Non-O157 Identification Kit PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001131 Prolex E. coli O26 Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001148 Prolex E. coli O45 Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001155 Prolex E. coli O103 Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001162 Prolex E. coli O111 Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001179 Prolex E. coli O121 Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001186 Prolex E. coli O145 Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001193 Prolex E. coli Non-O157 Negative Control Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001209 Prolex E. coli O91 Latex Reagent PRO-LAB, INCORPORATED GNA 2022-12-26 10628429001216 E. coli O157 Antiserum (3ml) PRO-LAB, INCORPORATED GNA 2022-12-26 05032384028511 VET-RPLAKIT OXOID LIMITED GNA 2022-12-12 05032384013142 E. COLI O157 TEST KIT OXOID LIMITED GNA 2022-12-08 05032384034420 DRYSPOT E. COLI O157 OXOID LIMITED GNA 2022-12-04 05713106544013 E. coli H4 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544020 E. coli H5 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544044 E. coli H6 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544068 E. coli H7 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544075 E. coli H8 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544099 E. coli H9 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544105 E. coli H10 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544129 E. coli H11 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544143 E. coli H12 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544167 E. coli H14 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544174 E. coli H15 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544198 E. coli H16 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544211 E. coli H17 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11 05713106544228 E. coli H18 serum, 5 mL Ssi Diagnostica A/S GNA 2021-08-11