FDA.reportPublic FDA data

IDS ACTH II

Primary DI
05060169696457
Brand
IDS ACTH II
Company
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Model
IS-4500NG
Published
2023-08-23
Public version status
New
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
CKGRadioimmunoassay, Acth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CKGRadioimmunoassay, ActhClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223867000IDS ACTH IIImmunodiagnostic Systems Limited2023-08-18CKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060169696457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060169696457050601696964575060169696457

GMDN Terms#

Term, Definition table
TermDefinition
Adrenocorticotropic hormone (ACTH) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the adrenocorticotropic hormone (ACTH) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in an upright position
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401915190660techsupport.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
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
05060169690141Urine CrossLaps® (CTX-I) EIAAC-03F12023-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870023847ACTH AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CKG2024-09-13
00816870024806ACTH AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CKG2024-09-13
00816870024844ACTH AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CKG2024-09-13
04048474036473ACTH (Adrenocorticotropic Hormone) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCKG2023-08-31
00083059070231ACTH [Adrenocorticotropic Hormone] ELISABIOMERICA, INC.CKG2020-07-01
00850002253160Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.CKG2019-05-20
00840239036476ACTH (Adrenocorticotropic Hormone) ELISADRG International IncCKG2019-03-20
B24221ACTHUE010Adrenocorticotropic Hormone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CKG2017-08-03
04015630939893Elecsys ACTHRoche Diagnostics GmbHCKG2017-04-21
08305900070231ACTH [Adrenocorticotropic Hormone] ELISABIOMERICA, INC.CKG2016-12-07
00817830022276ImmuChem hACTH Double Antibody 125I RIA KitMP BIOMEDICALS, LLCCKG2016-10-20
00817830022283ImmuChem hACTH Double Antibody 125I RIA KitMP BIOMEDICALS, LLCCKG2016-10-20
14560189212517ST AIA-PACK ACTHTOSOH CORPORATIONCKG2016-09-24
04560189212541AIA-PACK ACTH Sample Diluting SolutionTOSOH CORPORATIONCKG2016-09-24
00630414953502IMMULITE®/IMMULITE® 1000 Systems ACT ACTH Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCKG2016-09-24
00630414960999IMMULITE® 2000 Systems ACT ACTHSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCKG2016-09-24
00630414963532IMMULITE®/IMMULITE® 1000 Systems ACT ACTHSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCKG2016-09-24
04015630921522Elecsys ACTH Test SystemRoche Diagnostics GmbHCKG2016-09-20