Home GUDID 08028169204215 PhiCal Test
Primary DI 08028169204215
Brand PhiCal Test
Company EUROSPITAL SPA
Model 9053
Device description 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (IgG):1x15mL vial.3. Substrate: 1 x15 ml vial.4. Washing solution (20x): 1x50mL vial.5. Dilution solution (10x): 1 x20mL vial.6. Extraction solution (2.5x): 2x50 mL vials.7. Calibrators: 5 vials containing 1.0 ml Calprotectin at five known concentrations (6.25, 12.5, 25, 50, and 100 ng/ml).8. Control 1: 1x1.0 mL vial.9. Control 2: 1x1.0 mL vial.10. Microtiter plate cover: 1 piece.
Published 2016-09-14
Public version status Update
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 NXO Calprotectin, Fecal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NXO Calprotectin, Fecal Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08028169204215 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08028169204215 08028169204215 8028169204215
GMDN Terms# Term, Definition table Term Definition Calprotectin 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 calprotectin protein in a clinical specimen, using an enzyme immunoassay (EIA) method. This test is commonly used to aid in the diagnosis of inflammatory bowel disease or other causes of intestinal inflammation.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 429447667 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 B24280CALPHUIT2000 ALPCO Calprotectin Immunoturbidimetric Assay AMERICAN LABORATORY PRODUCTS COMPANY, LTD. NXO 2023-08-18 B24280CALPHUITCAL0 Calprotectin Immunoturbidimetric Assay - Calibrators AMERICAN LABORATORY PRODUCTS COMPANY, LTD. NXO 2023-08-18 B24280CALPHUITCON0 ALPCO Calprotectin Immunoturbidimetric Assay AMERICAN LABORATORY PRODUCTS COMPANY, LTD. NXO 2023-08-18 B24280CALPHUIT100 ALPCO Calprotectin Immunoturbidimetric Assay AMERICAN LABORATORY PRODUCTS COMPANY, LTD. NXO 2023-06-09 EBUHBKCALRSETUS0 BÜHLMANN fCAL® turbo Reagent Kit Bühlmann Laboratories AG NXO 2023-05-02 08056771602884 LIAISON Q.S.E.T. Device Plus Diasorin Inc. NXO 2022-08-09 04260714340007 fCAL turbo Bühlmann Laboratories AG NXO 2022-06-13 EBUHBEKCAL0 BÜHLMANN fCAL® ELISA Bühlmann Laboratories AG NXO 2019-11-06 08028169204710 EasyCal EUROSPITAL SPA NXO 2019-11-05 B24280CALPHUCH500 ALPCO Calprotectin Chemiluminescence ELISA AMERICAN LABORATORY PRODUCTS COMPANY, LTD. NXO 2019-11-04 EBUHBKCALRSET0 BÜHLMANN fCAL® turbo Reagent Kit Bühlmann Laboratories AG NXO 2019-11-01 B24280CALPHUCH010 ALPCO Calprotectin Chemiluminescence ELISA AMERICAN LABORATORY PRODUCTS COMPANY, LTD. NXO 2019-10-30 08426950846833 Fecal Extraction Device INOVA DIAGNOSTICS, INC. NXO 2018-11-30 08426950907206 QUANTA Flash® Calprotectin Reagents INOVA DIAGNOSTICS, INC. NXO 2018-02-28 08426950914693 QUANTA Flash Calprotectin Extraction Buffer INOVA DIAGNOSTICS, INC. NXO 2018-02-28 08426950913337 QUANTA LITE®Calprotectin Extended Range INOVA DIAGNOSTICS, INC. NXO 2016-12-15 08028169204246 Calprest NG EUROSPITAL SPA NXO 2016-11-30 08426950657484 QUANTA Lite® Calprotectin ELISA INOVA DIAGNOSTICS, INC. NXO 2016-08-31 08028169204093 Calprest EUROSPITAL SPA NXO 2016-07-04
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