FDA.reportPublic FDA data

Access Cortisol

Primary DI
15099590231118
Brand
Access Cortisol
Company
Beckman Coulter, Inc.
Model
33600
Catalog number
33600
Device description
The Access Cortisol Assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
Published
2016-09-09
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
15099590231118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959023111815099590231118

GMDN Terms#

Term, Definition table
TermDefinition
Free cortisol IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free cortisol in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
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
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16

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
10758750008377VITROSORTHO CLINICAL DIAGNOSTICSCGR2016-08-26