FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740005290
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
3K01-01
Catalog number
03K0101
Device description
Salicylate Calibrator
Published
2016-09-09
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
DKJCOLORIMETRY, SALICYLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKJColorimetry, SalicylateClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740005290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740005290003807400052903807400052900380740005290

GMDN Terms#

Term, Definition table
TermDefinition
Salicylate 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 salicylate in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature029 Degrees Celsius
Special Storage Condition, Specify00Do no freeze.
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
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
00630414654256Atellica CH Salicylate (SalC)Siemens Healthcare Diagnostics Inc.DKJ2025-10-15
07613336121504SalicyclateRoche Diagnostics GmbHDKJ2020-03-05
00628063401123Salicylate AssaySEKISUI DIAGNOSTICS, LLCDKJ2018-11-28
00380740135614AlinityABBOTT LABORATORIESDKJ2018-08-08
00630414595887Atellica CH SalSiemens Healthcare Diagnostics Inc.DKJ2017-12-27
05055273209396SALRANDOX LABORATORIES LIMITEDDKJ2016-09-24
00842768001611Syva® Emit® tox™ Salicylic Acid AssaySiemens Healthcare Diagnostics Inc.DKJ2016-09-24
00842768005435Dimension® Flex® reagent cartridge SALSiemens Healthcare Diagnostics Inc.DKJ2016-09-24
00842768015427Dimension Vista® Flex® reagent cartridge SALSiemens Healthcare Diagnostics Inc.DKJ2016-09-24
00842768023347Emit® tox™ Salicylic Acid AssaySiemens Healthcare Diagnostics Inc.DKJ2016-09-24
00884883001152DRI Salicylate Calibrator KitMicrogenics CorporationDKJ2016-09-24
00630414498959ADVIA® Chemistry SAL Salicylate ReagentsSiemens Healthcare Diagnostics Inc.DKJ2016-09-24
04015630992256SalicylateRoche Diagnostics GmbHDKJ2016-09-23
00657498001011Salicylate Liqui-UV®STANBIO LABORATORY, L.P.DKJ2016-09-23
04015630915897SalicylateRoche Diagnostics GmbHDKJ2016-09-20
00628063400867SALICYLATE-SL AssaySEKISUI DIAGNOSTICS, LLCDKJ2016-09-16
00884883001145DRI Salicylate Serum Tox AssayMicrogenics CorporationDKJ2016-09-12
00380740005306ARCHITECTABBOTT LABORATORIESDKJ2016-09-09
10758750008773VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DKJ2016-08-26
15099590222116SynchronBeckman Coulter, Inc.DKJ2016-08-24