FDA.reportPublic FDA data

ALPCO Calprotectin Immunoturbidimetric Assay

Primary DI
B24280CALPHUITCON0
Brand
ALPCO Calprotectin Immunoturbidimetric Assay
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
80-CALPHU-ITCON
Catalog number
80-CALPHU-ITCON
Device description
The Calprotectin Immunoturbidimetric Assay - Controls is an accessory used in conjunction with the Calprotectin Immunoturbidimetric Assay (80-CALPHU-IT200) by trained laboratory personnel.
Published
2023-08-18
Public version status
New
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
K220763000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220763000ALPCO Calprotectin Immunoturbidimetric AssayALPCO2023-04-13NXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B24280CALPHUITCON0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Calprotectin IVD, kit, nephelometry/turbidimetryA 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 a nephelometry/turbidimetry 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

Contacts#

Phone, Email table
PhoneEmail
800.592.5726cs@alpco.com

Regulatory Flags#

DUNS number
784143778
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
B24280LACHUFC9000ALPCO Lactoferrin CLIA Kit80-LACHU-FC90080-LACHU-FC9002026-03-31
B24230PANHUE010Pancreatic Elastase ELISA30-PANHU-E0130-PANHU-E012020-07-17
B24280EZDEV21000Unfilled Easy 2 Stool Extraction Device80-EXDEV2-10080-EXDEV2-1002026-02-02
B24280EZEX21000Easy 2 Stool Extraction Device80-EZEX2-10080-EZEX2-1002025-10-30
B24280CALPHUCH500ALPCO Calprotectin Chemiluminescence ELISA80-CALPHU-CH5080-CALPHU-CH502019-11-04
B24224MABHUE010Microalbumin ELISA24-MABHU-E0124-MABHU-E012018-01-16
B24280LACHUFCSET0Lactoferrin CLIA Re-Calibrator and Control Set80-LACHU-FCSET2025-06-06
B24280PANHUFCSET0Pancreatic Elastase CLIA Re-Calibrator and Control Set80-PANHU-FCSET2025-06-06
B24225TT4HUE010Total Thyroxine ELISA (Total T4 ELISA)25-TT4HU-E0125-TT4HU-E012017-08-03
B24211PREHUE010Pregnenolone ELISA11-PREHU-E0111-PREHU-E012020-09-25
B24280PANHUCH500Pancreatic Elastase Chemiluminescence ELISA80-PANHU-CH5080-PANHU-CH502022-09-09
B24280LACHUFC1000ALPCO Lactoferrin CLIA Kit80-LACHU-FC10080-LACHU-FC1002025-03-03
B24211HGHHUE010Human Growth Hormone ELISA11-HGHHU-E0111-HGHHU-E012025-01-20
B24280PANHUFC1000ALPCO Pancreatic Elastase CLIA80-PANHU-FC10080-PANHU-FC1002024-07-25
B24280PANHUCH010Pancreatic Elastase Chemiluminescence ELISA80-PANHU-CH0180-PANHU-CH012022-09-09
B24211GLUHUE010Glucagon ELISA11-GLUHU-E0111-GLUHU-E012024-10-23
B24220TT3HUE011Total Triiodothyronine (Total T3) ELISA20-TT3HU-E0120-TT3HU-E012024-07-22
B24280CALPHUIT2000ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-IT20080-CALPHU-IT2002023-08-18
B24280CALPHUITCAL0Calprotectin Immunoturbidimetric Assay - Calibrators80-CALPHU-ITCAL80-CALPHU-ITCAL2023-08-18
B24280CALPHUIT100ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-IT10080-CALPHU-IT1002023-06-09

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
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
08426950657484QUANTA Lite® Calprotectin ELISAINOVA DIAGNOSTICS, INC.NXO2016-08-31
08028169204093CalprestEUROSPITAL SPANXO2016-07-04