Calprest NG

Primary DI
08028169204246
Brand
Calprest NG
Company
EUROSPITAL SPA
Model
9069
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: 6 vials containing 1.5 ml Calprotectin at six known concentrations (0, 2.5, 12.5, 25, 50 and 150 ng/ml).8. Control 1: 1x1.5 mL vial.9. Control 2: 1x1.5 mL vial.10. Stop Solution: 1x15 mL vial10. Microtiter plate cover: 1 piece.
Published
2016-11-30
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
K160447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160447000Calprest NGEurospital S.P.A.2016-11-10NXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08028169204246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08028169204246080281692042468028169204246

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 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
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
429447667
Device count
1
Kit
true
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
08028169204710EasyCal90622019-11-05
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
08028169204710EasyCalEUROSPITAL SPANXO2019-11-05
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
08028169204215PhiCal TestEUROSPITAL SPANXO2016-09-14
08426950657484QUANTA Lite® Calprotectin ELISAINOVA DIAGNOSTICS, INC.NXO2016-08-31
08028169204093CalprestEUROSPITAL SPANXO2016-07-04