FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740156398
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
06K5523
Catalog number
06K5523
Device description
Quantia ASO Control II
Published
2020-03-03
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
JJTEnzyme controls (assayed and unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJTEnzyme Controls (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K984437000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984437000QUANTEX ASO-CRP-RP CONTROL IIInstrumentation Laboratory CO1999-02-02JJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740156398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740156398003807401563983807401563980380740156398

GMDN Terms#

Term, Definition table
TermDefinition
Plasma protein IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of plasma proteins in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Handling Environment Temperature029 Degrees Celsius
Special Storage Condition, Specify00Do not freeze.
Storage Environment Temperature00
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
Device count
1
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00893038002944Cholestech LDX™Alere San Diego, Inc.JJT2023-12-20
00380740156381ARCHITECTABBOTT LABORATORIESJJT2020-03-03
04015630947119PreciControl ISDRoche Diagnostics GmbHJJT2019-01-14
04015630947126CalCheck ISDRoche Diagnostics GmbHJJT2019-01-14
00380740044831ARCHITECTABBOTT LABORATORIESJJT2018-07-31
00380740045593ARCHITECTABBOTT LABORATORIESJJT2018-07-31
00856743007024Cardiac Control MarkerMORE DIAGNOSTICS INCJJT2018-03-31
00856743007031Cardiac Marker ControlMORE DIAGNOSTICS INCJJT2018-03-31
00856743007048Cardiac Marker ControlMORE DIAGNOSTICS INCJJT2018-03-31
00893038002524Alere Cholestech LDX®Alere San Diego, Inc.JJT2018-03-30
00856743007017Cardiac Marker ControlMORE DIAGNOSTICS INCJJT2018-03-30
M52551340CK/LD Isoenzyme Control (5 x 2 mL)HELENA LABORATORIES CORPORATIONJJT2017-03-17
00847661001225LiquichekBIO-RAD LABORATORIES, INC.JJT2017-01-09
00847661001232LiquichekBIO-RAD LABORATORIES, INC.JJT2017-01-09
00847661002154LiquichekBIO-RAD LABORATORIES, INC.JJT2017-01-09
00852553007049Enzymer Verifier KitVERICHEM LABORATORIES, INC.JJT2016-11-29
00852553007056Enzymer ER Verifier KitVERICHEM LABORATORIES, INC.JJT2016-11-29
00852553007131Enzymer ER Verifier, Level GVERICHEM LABORATORIES, INC.JJT2016-11-29
00725609000205SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00725609000212SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00725609000441SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00725609000458SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00384840518902Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCJJT2016-09-22
00038481518505Prodigy AutoCode Blood Glucose Monitoring SystemPRODIGY DIABETES CARE, LLCJJT2016-09-22