FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740011222
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
6L31-20
Catalog number
06L3120
Device description
Quinidine
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
LBZENZYME IMMUNOASSAY, QUINIDINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBZEnzyme Immunoassay, QuinidineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052826000QMS QUINIDINE. QMS QUINIDINE CALIBRATORSSeradyn, Inc.2005-12-23LBZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740011222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740011222003807400112223807400112220380740011222

GMDN Terms#

Term, Definition table
TermDefinition
Quinidine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the cardiovascular drug quinidine in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature029 Degrees Celsius
Special Storage Condition, Specify00Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
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
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336147917ONLINE TDM QuinidineRoche Diagnostics GmbHLBZ2021-01-15
00884883005990QMS Quinidine ImmunoassayMicrogenics CorporationLBZ2016-09-26
00842768001048Syva® Emit® 2000 Qunidine AssaySiemens Healthcare Diagnostics Inc.LBZ2016-09-24
00842768001055Syva® Emit® 2000 Quinidine CalibratorsSiemens Healthcare Diagnostics Inc.LBZ2016-09-24
00842768023293Emit® 2000 Quinidine AssaySiemens Healthcare Diagnostics Inc.LBZ2016-09-24
00884883006003QMS Quinidine Immunoassay Calibrator SetMicrogenics CorporationLBZ2016-09-22
04015630999262QuinidineRoche Diagnostics GmbHLBZ2016-09-20
04015630915873QuinidineRoche Diagnostics GmbHLBZ2016-09-20
00380740011215ARCHITECTABBOTT LABORATORIESLBZ2016-06-06