FDA.reportPublic FDA data

Future Diagnostics

Primary DI
08719326045214
Brand
Future Diagnostics
Company
Future Diagnostics Solutions B.V.
Model
4K-IPT-00
Device description
Immunoassay Kit
Published
2016-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719326045214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719326045214087193260452148719326045214

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
Special Storage Condition, Specify00Store at 2-8°C Upon Receipt

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 855 236 0910Pit.H@future-diagnostics.nl

Regulatory Flags#

DUNS number
489648538
Device count
1
Lot or batch
true
Expiration date on label
true

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