Home GUDID 00840733101724
PREMIER EHEC
Primary DI 00840733101724
Brand PREMIER EHEC
Company MERIDIAN BIOSCIENCE, INC.
Model 608096
Catalog number 608096
Device description The Premier EHEC test is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II (Verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. coli (EHEC) infections.
Published 2020-10-06
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
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 00840733101724 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 00840733101724 00840733101724 840733101724 0840733101724
GMDN Terms# Term, Definition table Term Definition Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate, using an enzyme immunoassay (EIA) method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 092815364 Device count 1 Kit true Lot or batch 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 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 00848838026768 REMEL REMEL, INC. GNA 2022-12-23 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