FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740105327
Brand
ARCHITECT
Company
Abbott GmbH
Model
1P30-28
Catalog number
01P3028
Device description
ARCHITECT iVancomycin Reagent Kit
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
LEHRADIOIMMUNOASSAY, VANCOMYCIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEHRadioimmunoassay, VancomycinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123947000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123947000ARCHITECT IVANCOMYCINBiokit, S.A.2013-08-29LEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740105327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740105327003807401053273807401053270380740105327

GMDN Terms#

Term, Definition table
TermDefinition
Vancomycin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug vancomycin in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature030 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
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
07613336121627ONLINE TDM Vancomycin Gen.3Roche Diagnostics GmbHLEH2020-03-05
07613336157800ONLINE TDM Vancomycin Gen.3Roche Diagnostics GmbHLEH2020-03-05
00380740156237ARCHITECTAbbott GmbHLEH2020-03-03
00380740135348AlinityABBOTT LABORATORIESLEH2018-11-07
00630414596020Atellica CH VancSiemens Healthcare Diagnostics Inc.LEH2017-12-19
04015630934416ONLINE TDM Vancomyin Gen.3Roche Diagnostics GmbHLEH2016-10-13
04015630934447ONLINE TDM Vancomyin Gen.3Roche Diagnostics GmbHLEH2016-10-13
00842768001109Syva® Emit® 2000 Vancomycin AssaySiemens Healthcare Diagnostics Inc.LEH2016-09-24
00842768005763Dimension® Flex® reagent cartridge VANCSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00842768015533Dimension Vista® Flex® reagent cartridge VANCSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00842768023323Emit® 2000 Vancomycin AssaySiemens Healthcare Diagnostics Inc.LEH2016-09-24
00884883011182QMS Vancomycin ImmunoassayMicrogenics CorporationLEH2016-09-24
00630414121444ADVIA Centaur® Systems, ACS:180® Systems VANC CalibratorSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00630414121451ADVIA Centaur® Vancomycin CalibratorSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00630414126111ADVIA Centaur® VANC MCMSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00630414203928ADVIA Centaur® VANCSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00630414443096ADVIA Centaur® VANCSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00630414561967ADVIA® Chemistry VANC_2 Vancomycin_2 ReagentsSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00884883012837QMS Vancomycin ImmunoassayMicrogenics CorporationLEH2016-09-22
04015630915996VancomycinRoche Diagnostics GmbHLEH2016-09-20
04015630997978Vancomycin ONLINE TDM VancomycinRoche Diagnostics GmbHLEH2016-09-20
04015630998920VancomycinRoche Diagnostics GmbHLEH2016-09-20
04015630999392VancomycinRoche Diagnostics GmbHLEH2016-09-20
04015630997961Vancomycin ONLINE TDM VancomycinRoche Diagnostics GmbHLEH2016-09-20
10758750006731VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LEH2016-08-26
00884883011243QMS Vancomycin ImmunoassayMicrogenics CorporationLEH2016-08-26
15099590223342SynchronBeckman Coulter, Inc.LEH2016-08-24
00380740001711ARCHITECTAbbott GmbHLEH2016-06-06
00380740009847ARCHITECTABBOTT LABORATORIESLEH2016-06-06