FDA.reportPublic FDA data

STELLUX® Chemi Human Insulin ELISA

Primary DI
B24280INSHUCH010
Brand
STELLUX® Chemi Human Insulin ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
80-INSHU-CH01
Catalog number
80-INSHU-CH01
Device description
The ALPCO Insulin Chemiluminescence ELISA is designed for the quantitative determination of insulin in human serum, heparin plasma, and tissue culture supernatants. For in vitro diagnostic use.
Published
2020-07-17
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
CFPRadioimmunoassay, Immunoreactive Insulin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFPRadioimmunoassay, Immunoreactive InsulinClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B24280INSHUCH010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Insulin IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of insulin in a clinical specimen, using a chemiluminescent immunoassay 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
800.592.5726cs@alpco.com

Regulatory Flags#

DUNS number
784143778
Device count
1
Premarket exempt
true
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
B24280CALPHUITCON0ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-ITCON80-CALPHU-ITCON2023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00859410006269SalimetricsSALIMETRICS, LLCCFP2024-09-18
00859410006276SalimetricsSALIMETRICS, LLCCFP2024-09-18
04048474053616InsulinDRG Instruments Gesellschaft mit beschränkter HaftungCFP2023-09-01
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04048474029352Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2023-08-29
00840239053619InsulinDRG International IncCFP2023-08-26
00840239036087Anti-Insulin ELISADRG International IncCFP2023-08-25
00840239029355Insulin ELISADRG International IncCFP2023-08-24
06925912718871iFlash-InsulinShenzhen YHLO Biotech Co., Ltd.CFP2022-10-26
00404847429350Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2021-06-07
00404847436082Anti-Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2021-06-07
00404847453614InsulinDRG Instruments Gesellschaft mit beschränkter HaftungCFP2021-06-07
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B24280INSHUE100ALPCO Insulin ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
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B24280INSHUUE100ALPCO Ultrasensitive Insulin ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
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