FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740145392
Brand
ARCHITECT
Company
Abbott GmbH
Model
2K91-03
Catalog number
02K9103
Device description
ARCHITECT CA19-9XR Calibrators
Published
2017-05-01
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
JJXSingle (specified) analyte controls (assayed and unassayed)
NIGSYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic CancerImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052000000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052000000ARCHITECT CA 19-9XR ASSAYFujirebio Diagnostics,Inc.2005-10-25NIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740145392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740145392003807401453923807401453920380740145392

GMDN Terms#

Term, Definition table
TermDefinition
Cancer antigen 19-9 (CA19-9) 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 gastrointestinal and pancreatic cancer antigen 19-9 (CA19-9) in a clinical specimen.

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
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
07613336171516CalSet CalcitoninRoche Diagnostics GmbHJIT2026-06-01
07613336218341Elecsys CA 19-9Roche Diagnostics GmbHNIG2026-06-01
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLCJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
08058056685391Cystatin C CalibratorsSENTINEL CH. SPAJIT2025-09-16
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
14560189216331CL AIA-PACK Prolactin II ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14560189216638CL AIA-PACK hs-E2 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185395454CL AIA-PACK T3 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185399674CL AIA-PACK Progesterone ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185399728CL AIA-PACK LH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185400400CL AIA-PACK FSH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
10758750035380VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-05-20
10758750034628VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
10758750035069VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
10758750035076VITROSORTHO CLINICAL DIAGNOSTICSJJX2024-09-18
10758750034833VITROSORTHO CLINICAL DIAGNOSTICSNIG2024-04-25
10758750034918VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-04-25
00021292015091TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00021292015107TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
10758750032716VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-01-20
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14