FDA.reportPublic FDA data

Alinity

Primary DI
00380740153953
Brand
Alinity
Company
Abbott Ireland Diagnostics
Model
01R1821
Catalog number
01R1821
Device description
Alinity i BRAHMS PCT Reagent Kit 200 Tests
Published
2019-01-04
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
PMTDevice to detect and measure procalcitonin (PCT) in human clinical specimens
PRIProcalcitonin assay
PTFAssay to measure PCT to aid in the risk assessment of critically ill patients on their first day of ICU admission

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMTDevice To Detect And Measure Procalcitonin (Pct) In Human Clinical SpecimensMicrobiology2
PRIProcalcitonin AssayMicrobiology2
PTFAssay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu AdmissionMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740153953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740153953003807401539533807401539530380740153953

GMDN Terms#

Term, Definition table
TermDefinition
Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature030 Degrees Celsius
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
985307301
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
00380740168742Alinity04W020104W02012025-12-11
00380740168759Alinity04W021004W02102025-12-11
00380740168780Alinity04W022204W02222025-12-11
00380740197742Alinity04W212704W21272025-10-14
00380740213893Alinity04W210204W21022025-10-14
00380740213909Alinity04W211204W21122025-10-14
00380740136772Alinity06P020406P02042019-09-14
00380740136789Alinity06P035906P03592019-09-14
00380740136796Alinity06P021306P02132019-09-14
00380740136802Alinity06P021506P02152019-09-14
00380740136819Alinity06P026006P02602019-09-14
00380740150990Alinity09P412009P41202020-05-05
00380740154233Alinity09P414009P41402020-05-05
00380740154240Alinity09P424009P42402020-01-02
00380740154516Alinity09P422009P42202020-01-02
00380740001339ARCHITECT1L76-0101L76012016-06-06
00380740001346ARCHITECT1L76-2501L76252016-06-06
00380740001353ARCHITECT1L76-5501L76552016-06-06
00380740001360ARCHITECT1L77-0101L77012016-06-06
00380740001377ARCHITECT1L77-2501L77252016-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336236499Elecsys BRAHMS PCTRoche Diagnostics GmbHPRI2026-02-19
04051839013668DiaSys Procalcitonin FSDiaSys Diagnostic Systems GmbHPTF2025-08-01
15099590736002Access PCTBeckman Coulter, Inc.PTF2023-05-05
00630414238692DM EXL LOCI BRAHMS PCTSiemens Healthcare Diagnostics Inc.PRI2022-11-15
00630414238692DM EXL LOCI BRAHMS PCTSiemens Healthcare Diagnostics Inc.PMT2022-11-15
00630414298214DM EXL LOCI BRAHMS PCTSiemens Healthcare Diagnostics Inc.PMT2022-11-15
10758750032938VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
10758750032945VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
10758750033287VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
10758750033294VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
07613336166635Elecsys BRAHMS PCTRoche Diagnostics GmbHPRI2020-04-30
07613336166642Elecsys BRAHMS PCTRoche Diagnostics GmbHPRI2020-04-30
15099590719531Access PCTIMMUNOTECHPTF2020-01-31
00630414246550Atellica IM BRAHMS PCTSiemens Healthcare Diagnostics Inc.PRI2018-10-05
00630414246550Atellica IM BRAHMS PCTSiemens Healthcare Diagnostics Inc.PTF2018-10-05
00630414246550Atellica IM BRAHMS PCTSiemens Healthcare Diagnostics Inc.PMT2018-10-05
04987270234945Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.PRI2018-04-02
04987270234945Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.PMT2018-04-02
04987270235058Lumipulse G BRAHMS PCT Immunoreaction CartridgesFUJIREBIO INC.PMT2018-04-02
04987270235058Lumipulse G BRAHMS PCT Immunoreaction CartridgesFUJIREBIO INC.PRI2018-04-02
00380740138905ARCHITECTAbbott GmbHPRI2017-08-16
00380740138905ARCHITECTAbbott GmbHPTF2017-08-16
00380740138905ARCHITECTAbbott GmbHPMT2017-08-16
00380740138912ARCHITECTAbbott GmbHPTF2017-08-16
00380740138912ARCHITECTAbbott GmbHPRI2017-08-16
00380740138912ARCHITECTAbbott GmbHPMT2017-08-16
00380740139032ARCHITECTAbbott GmbHPMT2017-08-16
00380740139032ARCHITECTAbbott GmbHPRI2017-08-16
00380740139032ARCHITECTAbbott GmbHPTF2017-08-16
00380740139049ARCHITECTAbbott GmbHPMT2017-08-16