FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740003357
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
2K44-35
Catalog number
02K4435
Device description
ARCHITECT CA15-3 Reagent Kit
Published
2016-06-06
Public version status
Update
Distribution status
Not 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)
MOISYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
MOISystem, Test, Immunological, Antigen, TumorImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042732000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042732000ARCHITECT CA 15-3 ASSAYFujirebio Diagnostics,Inc.2004-12-22MOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740003357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740003357003807400033573807400033570380740003357

GMDN Terms#

Term, Definition table
TermDefinition
Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen using a chemiluminescent immunoassay method.

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
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
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

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14562185399728CL AIA-PACK LH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185400400CL AIA-PACK FSH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
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00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26