FDA.reportPublic FDA data

IDS-iSYS Intact PTH

Primary DI
05060169690264
Brand
IDS-iSYS Intact PTH
Company
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Model
IS-3200
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
CEWRadioimmunoassay, Parathyroid Hormone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEWRadioimmunoassay, Parathyroid HormoneClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103325000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103325000IDS-ISYS INTACT PTHImmunodiagnostic Systems , Ltd.2012-02-03CEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060169690264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060169690264050601696902645060169690264

GMDN Terms#

Term, Definition table
TermDefinition
Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of parathyroid hormone (PTH) [intact, whole, or truncated fragments] in a clinical specimen, using a chemiluminescent immunoassay method.

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 upright 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
00816870020402PTH Intact AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CEW2024-09-13
00816870023731PTH Whole & Intact AccuLite VAST CLIA Test System - 192 WellsMONOBIND, INC.CEW2024-09-13
00816870023748PTH Whole & Intact AccuLite VAST CLIA Test System - 96 WellsMONOBIND, INC.CEW2024-09-13
00816870023755PTH Whole & Intact AccuBind VAST ELISA Test System - 192 WellsMONOBIND, INC.CEW2024-09-13
00816870023762PTH Whole & Intact AccuBind VAST ELISA Test System - 96 WellsMONOBIND, INC.CEW2024-09-13
00816870024516PTH Intact AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CEW2024-09-13
00816870024523PTH Intact AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CEW2024-09-13
07613336170304Elecsys PTHRoche Diagnostics GmbHCEW2024-07-30
07613336217542Elecsys PTHRoche Diagnostics GmbHCEW2024-07-30
07613336224922Elecsys PTHRoche Diagnostics GmbHCEW2024-07-30
07613336224939Elecsys PTH STATRoche Diagnostics GmbHCEW2024-07-30
10758750032709VITROSORTHO CLINICAL DIAGNOSTICSCEW2024-01-20
20758750032706VITROSORTHO CLINICAL DIAGNOSTICSCEW2024-01-20
04048474036459PTH (Parathyroid) Intact ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEW2023-08-31
00630414954035IMMULITE® 2000 Systems INS Insulin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEW2020-09-24
00083059070224Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.CEW2020-07-01
00630414293745Atellica IM PTHSiemens Healthcare Diagnostics Inc.CEW2020-05-31
00380740156244ARCHITECTAbbott GmbHCEW2020-03-03
00850002253115Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.CEW2019-05-20
00850002253122Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.CEW2019-05-20
00850002253139Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.CEW2019-05-20
00840239036452PTH (Parathyroid) Intact ELISADRG International IncCEW2019-03-20
00630414592398ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.CEW2018-11-12
00380740136215AlinityAbbott GmbHCEW2018-10-24
00630414592336ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.CEW2018-08-21
00630414592343ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.CEW2018-08-21
00630414592381ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.CEW2018-08-21
00630414599441Atellica IM PTHSiemens Healthcare Diagnostics Inc.CEW2018-02-06
00630414599458Atellica IM PTHSiemens Healthcare Diagnostics Inc.CEW2018-02-06
B24221IPTHUE010PTH (Intact, 1-84) ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CEW2017-08-03