FDA.reportPublic FDA data

Tobramycin

Primary DI
04015630915934
Brand
Tobramycin
Company
Roche Diagnostics GmbH
Model
20737925322
Catalog number
20737925322
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LFWFLUORESCENCE POLARIZATION IMMUNOASSAY, TOBRAMYCIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFWFluorescence Polarization Immunoassay, TobramycinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964670000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964670000ROCHE COBAS-FP REAGENTS FOR TOBRAMYCINRoche Diagnostic Systems, Inc.1997-02-04LFW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630915934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630915934040156309159344015630915934

GMDN Terms#

Term, Definition table
TermDefinition
Tobramycin 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 tobramycin 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

Regulatory Flags#

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

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00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884883005631CEDIA Tobramycin II AssayMicrogenics CorporationLFW2016-09-12