FDA.reportPublic FDA data

VITROS

Primary DI
10758750032068
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
6844425
Catalog number
6844425
Device description
VITROS Immunodiagnostic Products Insulin Reagent Pack
Published
2018-01-12
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
CFPRADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750032065PackageGS130In Commercial Distribution
10758750032068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875003206520758750032065
1075875003206810758750032068

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

Regulatory Flags#

DUNS number
215865786
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750033287VITROS619773561977352020-05-16
10758750033294VITROS619557561955752020-05-16
10758750032891VITROS690004069000402025-12-30
10758750033522VITROS691223269122322025-12-30
10758750033539VITROS691223369122332025-12-30
10758750008322VITROS100940610094062020-04-08
10758750002061VITROS680215668021562015-12-22
10758750002504VITROS680230168023012015-12-22
10758750035366VITROS619945461994542025-05-20
10758750035373VITROS619945561994552025-05-20
10758750035380VITROS619945661994562025-05-20
20758750035363VITROS619945461994542025-05-20
20758750035370VITROS619945561994552025-05-20
20758750035387VITROS619945661994562025-05-20
10758750000203VITROS189683618968362016-08-26
10758750002801VITROS680245468024542014-10-22
10758750035465VITROS617444261744422023-11-22
10758750034420VITROS619996161999612021-11-08
10758750033355VITROS619991961999192021-03-22
10758750033362VITROS619992061999202021-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850049545723AccuDiag™ Insulin ELISADiagnostic Automation, Inc.CFP2026-01-27
00859410006269SalimetricsSALIMETRICS, LLCCFP2024-09-18
00859410006276SalimetricsSALIMETRICS, LLCCFP2024-09-18
04048474053616InsulinDRG Instruments Gesellschaft mit beschränkter HaftungCFP2023-09-01
04048474036084Anti-Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2023-08-31
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
B24280INSHUCH100STELLUX® Chemi Human Insulin ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUE010ALPCO Insulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUE100ALPCO Insulin ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUUE010ALPCO Ultrasensitive Insulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUUE100ALPCO Ultrasensitive Insulin ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
00630414461021ADVIA Centaur® IRISiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414466187ADVIA Centaur® IRI DILSiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414466200ADVIA Centaur® IRISiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414600444Atellica IM IRISiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414600468Atellica IM IRI DILSiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414600475Atellica IM IRI DILSiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414954028IMMULITE®/IMMULITE® Systems 1000 Systems INS Insulin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414966014IMMULITE® 2000 Systems INS InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414966045IMMULITE® 2000 Systems INS InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414966243IMMULITE®/IMMULITE® 1000 Systems INS InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414998954IMMULITE® INS Control InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
B24280INSHUCH010STELLUX® Chemi Human Insulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-07-17