FDA.reportPublic FDA data

ACTIVE Aldosterone RIA

Primary DI
15099590211592
Brand
ACTIVE Aldosterone RIA
Company
IMMUNOTECH s.r.o.
Model
DSL8600
Catalog number
DSL8600
Device description
Radioimmunoassay Kit for the quantitative measurement of aldosterone in human serum, plasma or urine.
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
CJMRadioimmunoassay, Aldosterone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJMRadioimmunoassay, AldosteroneClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943397000DSL ACTIVE ALDOSTERONE RIA (DSL 8600)Diagnostic Systems Laboratories, Inc.1995-02-13CJM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590211592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959021159215099590211592

GMDN Terms#

Term, Definition table
TermDefinition
Aldosterone IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of aldosterone in a clinical specimen, using a radioimmunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
360561849
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
15099590211509DHEA-S-7 RIADSL2700DSL27002023-07-06
15099590211523Ultra-sensitive Estradiol RIADSL4800DSL48002023-07-06
15099590211530ACTIVE Free Testosterone RIADSL4900DSL49002023-07-06
15099590211547Estrone-sulfate RIADSL5400DSL54002023-07-06
15099590211615Estrone RIADSL8700DSL87002023-07-06
15099590211622DHEA RIADSL8900DSL89002023-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870023854Aldosterone AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CJM2024-09-13
00816870023861Aldosterone AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CJM2024-09-13
00816870024769Aldosterone AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CJM2024-09-13
00816870024776Aldosterone AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CJM2024-09-13
00817830022269Aldosterone Double Antibody 125I RIA KitMP BIOMEDICALS, LLCCJM2016-10-20
05060169690363IDS-iSYS Aldosterone IMMUNODIAGNOSTIC SYSTEMS LIMITEDCJM2016-04-01