FDA.reportPublic FDA data

QUANTA Lite® Calprotectin ELISA

Primary DI
08426950657484
Brand
QUANTA Lite® Calprotectin ELISA
Company
INOVA DIAGNOSTICS, INC.
Model
704770
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 1.0 ml Calprotectin at six known concentrations (6.25, 12.5, 25, 50, 100 and 200 ng/ml).8. Control 1: 1x1.0 mL vial.9. Control 2: 1x1.0 mL vial.
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950657484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950657484084269506574848426950657484

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-545-9495support@inovadx.com

Regulatory Flags#

DUNS number
188354831
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
08426950514190QUANTA Lite® C1q CIC ELISA7046202026-04-20
08430793041140Aptiva® Optical Cleaning SolutionAC10032024-03-11
08426950454373QUANTA Lite® ANA ELISA7087502016-08-31
08426950456193NOVA Lite® HEp-2 ANA Kit7081002016-08-31
08426950593461NOVA Lite® HEp-2 ANA Kit7081012016-08-31
08426950593577NOVA Lite® ANA Kit with DAPI7081022016-08-31
08426950594208NOVA Lite® HEp-2 External EB Kits7042352016-08-31
08426950594857NOVA Lite® Auto AB Panel 7081802016-08-31
08426950595267NOVA Lite® HEp-2 External EB Kits7042302016-08-31
08430793040181Aptiva® CTD Essential Calibrators7231012023-12-14
08430793040198Aptiva® CTD Essential Controls7231022023-12-14
08426950506324NOVA Lite® ANA KSL Kit7083902016-08-31
08426950514008NOVA Lite® ANA KSL Kit7083802016-08-31
08426950514176NOVA Lite®Rat Liver , Kidney, Stomach Kit7041702016-08-31
08426950545798NOVA Lite®Rat Liver , Kidney, Stomach Kit7041802016-08-31
08426950593539NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach7081502016-08-31
08426950596387NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach7081552016-08-31
08426950621843NOVA Lite® DAPI ANA Kit7043202016-08-31
08426950627692QUANTA Flash PR3 Reagents7011352024-12-13
08430793040716Aptiva® APS IgG Reagent7251002024-03-11

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
08028169204246Calprest NGEUROSPITAL SPANXO2016-11-30
08028169204215PhiCal TestEUROSPITAL SPANXO2016-09-14
08028169204093CalprestEUROSPITAL SPANXO2016-07-04