FDA.reportPublic FDA data

IDS-iSYS Aldosterone

Primary DI
05060169690363
Brand
IDS-iSYS Aldosterone
Company
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Model
IS-3300
Published
2016-04-01
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
CJMRadioimmunoassay, Aldosterone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJMRadioimmunoassay, AldosteroneClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142994000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142994000IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration VerifiersImmunodiagnostic Systems , Ltd.2015-04-21CJM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060169690363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060169690363050601696903635060169690363

GMDN Terms#

Term, Definition table
TermDefinition
Aldosterone IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of aldosterone in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Prior to first use. Store the cartridge and calibrators in an upright position in the dark. Do not freeze the cartridge
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401915190660info.uk@idsplc.com

Regulatory Flags#

DUNS number
494268600
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
05060169690721IDS-iSYS Total TestosteroneN/AIS-50002026-04-17
05060169690875IDS-iSYS Total Testosterone Control SetN/AIS-50302026-04-17
05060169691063IDS-iSYS Total Testosterone Calibration VerifiersN/AIS-50352026-04-17
05060169691230IDS-iSYS Free TestosteroneIS-53002025-11-03
05060169691247IDS-iSYS Free Testosterone Control SetIS-53302025-11-03
05060169691254IDS-iSYS Free Testosterone Calibration VerifiersIS-53352025-11-03
05060169693968IDS-i10IS-8104002023-06-27
05060169691223IDS-iSYS Multi Discipline Automated SystemIS-3104002016-04-01
05060169695986IDS Beta CrossLaps® (CTX-I)IS-3000N2024-01-03
05060169696013IDS Beta CrossLaps® (CTX-I) Calibrator SetIS-3020N2024-01-03
05060169696051IDS Beta CrossLaps® (CTX-I) Control SetIS-3030N2024-01-03
05060169696457IDS ACTH IIIS-4500NG2023-08-23
05060169696495IDS ACTH II Calibrator SetIS-4520NG2023-08-23
05060169696532IDS ACTH II Control SetIS-4530NG2023-08-23
05060169691148IDS-iSYS SDSpeed CalcIS-SDSCALC2023-06-27
05060169691261IDS AndrostenedioneIS-54002023-06-27
05060169691278IDS Androstenedione Control SetIS-54302023-06-27
05060169692305IDS-iSYS D-Sorb SolutionIS-DS2002023-06-27
05060169693913IDS Top Cap SetIS-CAP3002023-06-27
05060169696099IDS Androstenedione Calibrator SetIS-54202023-06-27

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
15099590211592ACTIVE Aldosterone RIAIMMUNOTECH s.r.o.CJM2016-09-09