FDA.reportPublic FDA data

Vancomycin ONLINE TDM Vancomycin

Primary DI
04015630997961
Brand
Vancomycin ONLINE TDM Vancomycin
Company
Roche Diagnostics GmbH
Model
4642490190
Catalog number
4642490190
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K060586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060586000ENZYME IMMUNOASSAY, VANCOMYCINRoche Diagnostics Corp.2006-05-11LEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630997961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630997961040156309979614015630997961

GMDN Terms#

Term, Definition table
TermDefinition
Vancomycin 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 antimicrobial drug vancomycin in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14

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
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
00380740105327ARCHITECTAbbott GmbHLEH2016-06-06