FDA.reportPublic FDA data

IMMULITE 2000 Cortisol Kit Domestic 200T

Primary DI
00630414167404
Brand
IMMULITE 2000 Cortisol Kit Domestic 200T
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10901844
Catalog number
L2KCO2(D)
Device description
IMMULITE 2000 Cortisol Kit Domestic 200T
Published
2018-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGRRADIOIMMUNOASSAY, CORTISOL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGRRadioimmunoassay, CortisolClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202826000
K931409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202826000IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd.2021-01-15CGR
K931409000IMMULITE CORTISOLDiagnostic Products Corp.1993-05-11CGR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414167404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414167404006304141674046304141674040630414167404

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
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
296822794
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414965017IMMULITE®/IMMULITE® 1000 Systems SUBS10385394LSUBX2020-09-24
00630414961125IMMULITE® 2000 Systems CEA10380995L2KCE62016-09-24
00630414964980IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH10381430LSKPTZ2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T410381635LKT452016-09-24
00630414972923IMMULITE®2000 Systems Diluent Tube Caps10385211L2ZC2020-09-24
00630414965734IMMULITE® 2000 Systems Allergen Tube Caps10282837L2ATC2020-09-24
00630414965741IMMULITE® 2000 Systems Allergen Tubes10282849L2ATS22020-09-24
00630414973159IMMULITE® 2000 Systems Diluent Tubes10385210L2ZT2020-09-24
00630414974064IMMULITE® 2000 Systems Microsampling Tube Caps10385205LSMC2020-09-24
00630414954547IMMULITE® 2000 Systems Reaction Tubes10385206LRXT2016-09-24
00630414973937IMMULITE® 2000 Systems Microsampling Tubes10385207LMST2016-09-24
00630414982403IMMULITE® 2000 XPi Sample Nesting Cups103741789052882016-09-24
00630414982410IMMULITE® 2000 Xpi Sample Nesting Cups103741799052892016-09-24
00630414961538IMMULITE® 2000 Systems IGF-110381448L2KGF22020-09-24
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04

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
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
10758750008377VITROSORTHO CLINICAL DIAGNOSTICSCGR2016-08-26