FDA.reportPublic FDA data

EasyCal

Primary DI
08028169204710
Brand
EasyCal
Company
EUROSPITAL SPA
Model
9062
Published
2019-11-05
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
CodeName
NXOCalprotectin, Fecal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXOCalprotectin, FecalImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191589000
K191592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191589000Calprest, EasyCalEurospital S.P.A.2019-07-10NXO
K191592000CalprestNG, EasyCalEurospital S.P.A.2019-07-10NXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08028169204710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08028169204710080281692047108028169204710

GMDN Terms#

Term, Definition table
TermDefinition
Calprotectin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of calprotectin protein in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
429447667
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08028169204055a-Gliatest IgA91672016-07-04
08028169204062a-Gliatest IgG91682016-07-04
08028169204079a-GliaPep IgA91772016-07-04
08028169204086a-GliaPep IgG91782016-07-04
08028169204093Calprest90612016-07-04
08028169204215PhiCal Test90532016-09-14
08028169204246Calprest NG90692016-11-30
08028169204024Eu-tTG IgA91652016-07-01
08028169204048Eu-tTG IgG91662016-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B24280CALPHUIT2000ALPCO Calprotectin Immunoturbidimetric AssayAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NXO2023-08-18
B24280CALPHUITCAL0Calprotectin Immunoturbidimetric Assay - CalibratorsAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NXO2023-08-18
B24280CALPHUITCON0ALPCO Calprotectin Immunoturbidimetric AssayAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NXO2023-08-18
B24280CALPHUIT100ALPCO Calprotectin Immunoturbidimetric AssayAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NXO2023-06-09
EBUHBKCALRSETUS0BÜHLMANN fCAL® turbo Reagent KitBühlmann Laboratories AGNXO2023-05-02
08056771602884LIAISON Q.S.E.T. Device PlusDiasorin Inc.NXO2022-08-09
04260714340007fCAL turboBühlmann Laboratories AGNXO2022-06-13
EBUHBEKCAL0BÜHLMANN fCAL® ELISABühlmann Laboratories AGNXO2019-11-06
B24280CALPHUCH500ALPCO Calprotectin Chemiluminescence ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NXO2019-11-04
EBUHBKCALRSET0BÜHLMANN fCAL® turbo Reagent KitBühlmann Laboratories AGNXO2019-11-01
B24280CALPHUCH010ALPCO Calprotectin Chemiluminescence ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NXO2019-10-30
08426950846833Fecal Extraction DeviceINOVA DIAGNOSTICS, INC.NXO2018-11-30
08426950907206QUANTA Flash® Calprotectin ReagentsINOVA DIAGNOSTICS, INC.NXO2018-02-28
08426950914693QUANTA Flash Calprotectin Extraction BufferINOVA DIAGNOSTICS, INC.NXO2018-02-28
08426950913337QUANTA LITE®Calprotectin Extended RangeINOVA DIAGNOSTICS, INC.NXO2016-12-15
08028169204246Calprest NGEUROSPITAL SPANXO2016-11-30
08028169204215PhiCal TestEUROSPITAL SPANXO2016-09-14
08426950657484QUANTA Lite® Calprotectin ELISAINOVA DIAGNOSTICS, INC.NXO2016-08-31
08028169204093CalprestEUROSPITAL SPANXO2016-07-04