FDA.reportPublic FDA data

fCAL turbo

Primary DI
04260714340007
Brand
fCAL turbo
Company
Bühlmann Laboratories AG
Model
08910367190
Published
2022-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NXOCalprotectin, Fecal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXOCalprotectin, FecalImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260714340007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260714340007042607143400074260714340007

GMDN Terms#

Term, Definition table
TermDefinition
Calprotectin IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of calprotectin protein in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481261006
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EBUHBKPELARSET0BÜHLMANN fPELA® turbo Reagent KitB-KPELA-RSET2020-06-22
EBUHKKACK20BÜHLMANN ACE KineticKK-ACK2KK-ACK22025-06-27
EBUHKKACK21ACE Kinetic KitKK-ACK2KK-ACK22016-09-01
EBUHBCCRLYR20CAST® Lysing Reagent BasophilB-CCR-LYR202025-03-04
EBUHBCCRSR20CAST® Staining Reagent BasophilB-CCR-SR202025-03-04
EBUHBCCRSTB5CAST® Stimulation Buffer BasophilB-CCR-STB52025-03-04
EBUHBCCRSTCON10CAST® Stimulation Control BasophilB-CCR-STCON102025-03-04
EBUHBCCRWB10CAST® Wash Buffer BasophilB-CCR-WB102025-03-04
EBUHBKCALRSETUS0BÜHLMANN fCAL® turbo Reagent KitB-KCAL-RSET-US2023-05-02
EBUHBCALSAMPLER250Simple Sampler Stool Collection SetB-CAL-SAMPLER252023-06-26
EBUHBKPELACONSET0BÜHLMANN fPELA® turbo Control KitB-KPELA-CONSET2020-06-22
EBUHKPELACASET0BÜHLMANN fPELA® turbo Calibrator KitB-KPELA-CASET2020-06-22
07613336169926fCAL turbo089103321902020-05-27
EBUH089104991900fCAL Calibrator Set089104991902020-05-27
EBUHBEKCAL0BÜHLMANN fCAL® ELISAEK-CAL2019-11-06
EBUHBEKCAL20BÜHLMANN fCAL® ELISAEK-CAL22019-11-06
EBUHBKCALCASET0BÜHLMANN fCAL® turbo Calibrator KitB-KCAL-CASET2019-11-01
EBUHBKCALRSET0BÜHLMANN fCAL® turbo Reagent KitB-KCAL-RSET2019-11-01
EBUHBIPOCTRABS0Quantum Blue® ReaderBI-POCTR-ABS2021-01-12
EBUH089109870010CALEX Cap089109870012020-05-27

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
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