FDA.reportPublic FDA data

Alinity

Primary DI
00380740136215
Brand
Alinity
Company
Abbott GmbH
Model
08P3121
Catalog number
08P3121
Device description
Alinity i Intact PTH Reagent Kit 200 Tests
Published
2018-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K063232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063232000ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01Biokit, S.A.2007-06-19CEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740136215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740136215003807401362153807401362150380740136215

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
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
315786293
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
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

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
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
04015630939787Elecsys PTHRoche Diagnostics GmbHCEW2017-04-21