FDA.reportPublic FDA data

Alinity

Primary DI
00380740160623
Brand
Alinity
Company
ABBOTT IRELAND
Model
07P5131
Catalog number
07P5131
Device description
Alinity i Total B-hCG Reagent Kit 1200 Tests
Published
2019-04-10
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
DHASYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHASystem, Test, Human Chorionic GonadotropinClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740160623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740160623003807401606233807401606230380740160623

GMDN Terms#

Term, Definition table
TermDefinition
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, 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
989964119
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
00380740155322Alinity04T992004T99202025-12-19
00380740155339Alinity04T993004T99302025-12-19
00380740155612Alinity04T852004T85202025-12-19
00380740156718ARCHITECT04S892004S89202025-12-19
00380740195236ARCHITECT04T032004T03202025-12-19
00380740195243ARCHITECT04T033004T03302025-12-19
00380740106003ARCHITECT7K78-3507K78352025-12-12
00380740180713Alinity04U002004U00202025-10-24
00380740180720ARCHITECT04T042004T04202025-10-24
00380740204020ARCHITECT04T040104T04012025-10-24
00380740204037Alinity04U000104U00012025-10-24
00380740130572Alinity07P944007P94402020-07-03
00380740014346ARCHITECT7K64-5007K64502016-09-09
00380740155285Alinity04T822004T82202024-08-15
00380740155292Alinity04T823004T82302024-08-15
00380740155346Alinity04U302004U30202024-08-15
00380740155353Alinity04U303004U30302024-08-15
00380740155483ARCHITECT04U452004U45202024-08-15
00380740155490ARCHITECT04U453004U45302024-08-15
00380740155872ARCHITECT04T342004T34202024-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740106003ARCHITECTABBOTT IRELANDDHA2025-12-12
20612479280124McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-12-10
10612479280172McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-12-10
00380740215712AlinityABBOTT LABORATORIESDHA2025-10-08
20612479279715McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-09-10
10758750034291VITROSORTHO CLINICAL DIAGNOSTICSDHA2024-09-18
20758750034298VITROSORTHO CLINICAL DIAGNOSTICSDHA2024-09-18
07613336217535Elecsys HCG+ betaRoche Diagnostics GmbHDHA2024-06-03
06947145578039MAGLUMI 2000 HCG/beta-HCGShenzhen New Industries Biomedical Engineering Co., Ltd.DHA2024-05-11
06947145578046MAGLUMI 2000 HCG/beta-HCGShenzhen New Industries Biomedical Engineering Co., Ltd.DHA2024-05-11
06925912718703iFlash-HCGShenzhen YHLO Biotech Co., Ltd.DHA2024-01-30
00695684893019Pregcolor PlusGERMAINE LABORATORIES, INCDHA2023-08-09
00695684971014Pregcolor Premium GERMAINE LABORATORIES, INCDHA2023-08-09
04987270235232Lumipulse G BHCG Immunoreaction CartridgesFUJIREBIO INC.DHA2023-02-01
15099590744380Access Total BhCG (5th IS)Beckman Coulter, Inc.DHA2023-01-06
08806388243310Multi-unit Angled AbutmentMegagen Implant Co. LtdDHA2021-11-17
07613336169216Elecsys HCG Test SystemRoche Diagnostics GmbHDHA2021-09-24
07613336169223Elecsys HCG Test SystemRoche Diagnostics GmbHDHA2021-09-24
00695684957018Mosie Baby Pregnancy TestGERMAINE LABORATORIES, INCDHA2019-10-21
06956848940166Mosie Baby Pregnancy TestGERMAINE LABORATORIES, INCDHA2019-10-21
00816862021639PreviewWONDFO USA CO., LTD.DHA2019-03-06
00816870020570Free B-hCG XR AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020587Free B-hCG XR AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870020921hCG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020938Monobind AccuBind hCG ELISA Kit - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870020945hCG Extended Range AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020952hCG Extended Range AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870022253Monobind AccuLite Free B-hCG XR CLIA Kit - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870022260Monobind AccuLite Free B-hCG XR CLIA Kit - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870022581Monobind AccuLite hCG CLIA Kit - 96 WellsMONOBIND, INC.DHA2019-02-11