FDA.reportPublic FDA data

ADVIA® Chemistry GENT_2 Gentamicin_2 Reagents

Primary DI
00630414561943
Brand
ADVIA® Chemistry GENT_2 Gentamicin_2 Reagents
Company
Siemens Healthcare Diagnostics Inc.
Model
10377507
Catalog number
10377507
Device description
Gentamicin - ADVIA Chem. - RGT - 4x100 tests
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCDENZYME IMMUNOASSAY, GENTAMICIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCDEnzyme Immunoassay, GentamicinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962519000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962519000EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORSBehring Diagnostics, Inc.1996-09-04LCD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414561943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414561943006304145619436304145619430630414561943

GMDN Terms#

Term, Definition table
TermDefinition
Gentamicin 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 gentamicin in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze, Avoid prolonged exposure to temperatures above 32°C
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740193645ARCHITECTAbbott GmbHLCD2026-04-28
07613336190807CEDIA Gentamicin II (GENTC)Microgenics CorporationLCD2020-06-23
00884883007123GENTCMicrogenics CorporationLCD2019-11-20
00380740135522AlinityABBOTT LABORATORIESLCD2018-12-31
00630414595979Atellica CH GentSiemens Healthcare Diagnostics Inc.LCD2017-12-21
05055273206449GENTRANDOX LABORATORIES LIMITEDLCD2016-09-24
00842768001086Syva® Emit® 2000 Gentamicin Plus AssaySiemens Healthcare Diagnostics Inc.LCD2016-09-24
00842768001093Syva® Emit® 2000 Gentamicin Plus CalibratorsSiemens Healthcare Diagnostics Inc.LCD2016-09-24
00842768005336Dimension® Flex® reagent cartridge GENTSiemens Healthcare Diagnostics Inc.LCD2016-09-24
00842768015212Dimension Vista® Flex® reagent cartridge GENTSiemens Healthcare Diagnostics Inc.LCD2016-09-24
00842768023316Emit® 2000 Gentamicin Plus AssaySiemens Healthcare Diagnostics Inc.LCD2016-09-24
00884883001312CEDIA Gentamicin II AssayMicrogenics CorporationLCD2016-09-24
00884883012677QMS Gentamicin AssayMicrogenics CorporationLCD2016-09-24
00630414527277ADVIA Centaur® GENTSiemens Healthcare Diagnostics Inc.LCD2016-09-24
00630414527284ADVIA Centaur® Systems, ACS:180® Systems GENT CalibratorSiemens Healthcare Diagnostics Inc.LCD2016-09-24
00630414527291ADVIA Centaur® Systems Gentamicin CalibratorSiemens Healthcare Diagnostics Inc.LCD2016-09-24
00630414527307ADVIA Centaur® Gentamicin MCMSiemens Healthcare Diagnostics Inc.LCD2016-09-24
00884883011205QMS Gentamycin ImmunoassayMicrogenics CorporationLCD2016-09-22
04015630994939CEDIA Gentamicin IIRoche Diagnostics GmbHLCD2016-09-20
00380740001735ARCHITECTAbbott GmbHLCD2016-09-09
00380740001742ARCHITECTAbbott GmbHLCD2016-09-09
15099590232061SynchronBeckman Coulter, Inc.LCD2016-08-24
10758750006755VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LCD2016-08-10
00380740000301ARCHITECTABBOTT LABORATORIESLCD2016-06-06