FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740003180
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
2K41-01
Catalog number
02K4101
Device description
ARCHITECT STAT Troponin-I Calibrators
Published
2016-06-06
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
JITCALIBRATOR, SECONDARY
MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2
MMIImmunoassay Method, Troponin SubunitClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740003180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740003180003807400031803807400031800380740003180

GMDN Terms#

Term, Definition table
TermDefinition
Troponin I IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
079226220
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
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03
00380740202835Alinity06P012506P01252025-10-03
00380740202859Alinity06P016106P01612025-10-03
00380740202996Alinity06P080706P08072025-09-17
00380740203023Alinity06P081506P08152025-09-17
00380740203030Alinity06P082506P08252025-09-17
00380740203054Alinity06P086106P08612025-09-17
00380740196257GLP systems Track04Z965104Z96512023-08-30
00380740225186ARCHITECT04P553004P55302026-05-14
00380740225193ARCHITECT04P573304P57332026-05-14
00380740003197ARCHITECT2K41-1002K41102016-06-06
00380740138851Alinity09P680109P68012023-11-16
00380740138868Alinity09P690109P69012023-11-16
00380740203191Alinity06P023006P02302025-09-24
00380740203214Alinity06P020606P02062025-09-24
00380740203238Alinity06P022006P02202025-09-24
00380740203252Alinity06P026106P02612025-09-24
00380740203276Alinity06P035806P03582025-09-24
00380740202958Alinity06P060706P06072025-09-24

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08058056685391Cystatin C CalibratorsSENTINEL CH. SPAJIT2025-09-16
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14562185399728CL AIA-PACK LH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185400400CL AIA-PACK FSH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
00630414611204Atellica CH UAlb CALSiemens Healthcare Diagnostics Inc.JIT2025-08-11
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10758750034628VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
10758750035069VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
10758750034918VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-04-25
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00811403013180Buffer PackDiamond Diagnostics Inc.JIT2023-06-05
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00630414238708DM EXL LOCI BRAHMS PCT Cal KitSiemens Healthcare Diagnostics Inc.JIT2022-11-15
00630414610870Atellica CH LDLC CALSiemens Healthcare Diagnostics Inc.JIT2022-07-08
00630414600338Atellica™ IM VitDSiemens Healthcare Diagnostics Inc.JIT2021-05-28
00630414607047DV/DM COV2G/CV2G CALSiemens Healthcare Diagnostics Inc.JIT2021-01-22
14987481100999NEFA Standard SolutionFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIT2020-10-23
00630414293523Atellica IM Calibrator 30Siemens Healthcare Diagnostics Inc.JIT2020-05-31
00630414279190Atellica CH UCFP CalibratorSiemens Healthcare Diagnostics Inc.JIT2020-03-09
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