FDA.reportPublic FDA data

Cortisol CT 500 Tube Kit

Primary DI
00817830022610
Brand
Cortisol CT 500 Tube Kit
Company
MP BIOMEDICALS, LLC
Model
07-221105
Catalog number
07-221105
Device description
For the quantitative determination of Cortisol in Serum or Plasma.
Published
2017-01-09
Public version status
Update
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
CGRRADIOIMMUNOASSAY, CORTISOL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGRRadioimmunoassay, CortisolClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K842365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K842365000CORTI-COTE CORTISOL SOLID PHASE RADIOBd Becton Dickinson Vacutainer Systems Preanalytic1984-08-16CGR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817830022610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817830022610008178300226108178300226100817830022610

GMDN Terms#

Term, Definition table
TermDefinition
Total cortisol IVD, kit, radioimmunoassayA 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 radioimmunoassay method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25.4Centimeter

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(800)854-0530custserv@mpbio.com

Regulatory Flags#

DUNS number
137825928
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817830023211MP Biomedicals LLC07189105071891052023-08-03
00817830023228MP Biomedicals LLC07596303075963032023-08-03
00817830023235MP Biomedicals LLC07596307075963072023-08-03
00817830023006MP Biomedicals LLC06B25501706B2550172023-08-02
00817830023075MP Biomedicals LLC07140202071402022023-08-02
00817830023082MP Biomedicals LLC07140205071402052023-08-02
00817830023099MP Biomedicals LLC07553300075533002023-08-02
00817830023105MP Biomedicals LLC07553303075533032023-08-02
00817830023112MP Biomedicals LLC07553305075533052023-08-02
00817830023129MP Biomedicals LLC07553306075533062023-08-02
00817830023136MP Biomedicals LLC06B25502506B2550252023-08-02
00817830023143MP Biomedicals LLC07152101071521012023-08-02
00817830023150MP Biomedicals LLC07171102071711022023-08-02
00817830023167MP Biomedicals LLC07170102071701022023-08-02
00817830023174MP Biomedicals LLC07170105071701052023-08-02
00817830023181MP Biomedicals LLC07270102072701022023-08-02
00817830023198MP Biomedicals LLC07270105072701052023-08-02
00817830023204MP Biomedicals LLC07189102071891022023-08-02
00817830023013MP Biomedicals LLC07109202071092022023-08-01
00817830023020MP Biomedicals LLC07230102072301022023-08-01

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
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