FDA.reportPublic FDA data

IDS-iSYS Human Growth Hormone (hGH)

Primary DI
05060169690332
Brand
IDS-iSYS Human Growth Hormone (hGH)
Company
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Model
IS-3700
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
CFLRadioimmunoassay, Human Growth Hormone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFLRadioimmunoassay, Human Growth HormoneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060169690332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060169690332050601696903325060169690332

GMDN Terms#

Term, Definition table
TermDefinition
Human growth hormone (HGH) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of human growth hormone (HGH) 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 in an upright position in the dark. Do not freeze the cartridge or the calibrators.
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
Premarket exempt
true
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
00850049545815AccuDiag™ Human Growth Hormone (HGH) ELISADiagnostic Automation, Inc.CFL2026-01-27
B24211HGHHUE010Human Growth Hormone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFL2025-01-20
04048474018646TGF-Beta 1 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2024-11-22
04048474023961TGF-Beta 2 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2024-11-22
00816870024813IGF-1 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CFL2024-09-13
00816870024820IGF-1 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CFL2024-09-13
00816870024882IGF-1 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CFL2024-09-13
00816870024899IGF-1 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CFL2024-09-13
04048474041408IGF-1 600 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2023-08-31
04048474017878Human Growth Hormone (HGH) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2023-08-26
00840239041401IGF-1 600 ELISADRG International IncCFL2023-08-25
00840239035523HGH (Human Growth Hormone) ELISADRG International IncCFL2023-08-24
00840239018649TGF-B1 ELISADRG International IncCFL2023-08-23
00840239023964TGF-B2 ELISADRG International IncCFL2023-08-23
B261CANGH40700DBC Growth Hormone (GH) ELISADiagnostics Biochem Canada IncCFL2022-11-15
06925912719281iFlash-hGHShenzhen YHLO Biotech Co., Ltd.CFL2022-10-26
03770024321562HGH-USCISBIO BIOASSAYSCFL2021-12-07
00404847441406IGF-1 600 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2021-06-11
00840239017871Human Growth Hormone (HGH) ELISADRG International IncCFL2021-06-09
00404847418644TGF-Beta 1 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2021-06-07
00404847423969TGF-Beta 2 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2021-06-07
04015630926664Elecsys hGHRoche Diagnostics GmbHCFL2021-01-18
00630414601236IMMULITE® 2000 Systems IGF-ISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414601243IMMULITE®/IMMULITE® 1000 Systems IGF-ISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414953212IMMULITE® Systems IG1 CONTROL IGF-1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414953809IMMULITE®/IMMULITE® 1000 Systems GH Growth Hormone Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414953922IMMULITE® 2000 Systems IG1 IGF-I Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414961538IMMULITE® 2000 Systems IGF-1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414961552IMMULITE 2000 Systems Growth HormoneSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414964041IMMULITE®/IMMULITE® 1000 Systems IG1 IGF-1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24