FDA.reportPublic FDA data

VITROS

Primary DI
10758750008377
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
1074053
Catalog number
1074053
Device description
VITROS Immunodiagnostic Products Cortisol Reagent Pack
Published
2016-08-26
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
CGRRADIOIMMUNOASSAY, CORTISOL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGRRadioimmunoassay, CortisolClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750008374PackageGS130In Commercial Distribution
10758750008377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000837420758750008374
1075875000837710758750008377

GMDN Terms#

Term, Definition table
TermDefinition
Total cortisol IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cortisol in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215865786
Device count
1
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
00850049545242AccuDiag ™Diagnostic Automation, Inc.CGR2024-01-30
05060169690691IDS CortisolIMMUNODIAGNOSTIC SYSTEMS LIMITEDCGR2021-04-14
00816870021317Cortisol AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CGR2019-02-11
00816870021324Cortisol AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CGR2019-02-11
00816870022758Cortisol AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CGR2019-02-11
00816870022765Monobind AccuLite Cortisol CLIA Kit - 192 WellsMONOBIND, INC.CGR2019-02-11
00630414167404IMMULITE 2000 Cortisol Kit Domestic 200TSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGR2018-01-15
00630414167411IMMULITE 2000 Crotisol Kit Domestic 600TSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGR2018-01-15
00817830022610Cortisol CT 500 Tube KitMP BIOMEDICALS, LLCCGR2017-01-09
00817830022627Cortisol CT 1000 Tube KitMP BIOMEDICALS, LLCCGR2017-01-09
00817830022306ImmuChem Cortisol Coated Tube 125I RIA KitMP BIOMEDICALS, LLCCGR2016-10-20
00817830022313Corti-Cote 125I RIA KitMP BIOMEDICALS, LLCCGR2016-10-20
00630414953649IMMULITE®/IMMULITE® 1000 Systems COR Cortisol Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGR2016-09-24
00630414961187IMMULITE® 2000 Systems COR CortisolSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGR2016-09-24
00630414961194IMMULITE® 2000 Systems COR CortisolSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGR2016-09-24
00630414963761IMMULITE®/IMMULITE® 1000 Systems COR CortisolSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGR2016-09-24
15099590231118Access CortisolBeckman Coulter, Inc.CGR2016-09-09