FDA.reportPublic FDA data

Gentamicin

Primary DI
04015630915712
Brand
Gentamicin
Company
Roche Diagnostics GmbH
Model
20737844322
Catalog number
20737844322
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
LCQFLUORESCENT IMMUNOASSAY GENTAMICIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCQFluorescent Immunoassay GentamicinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945523000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945523000COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORSRoche Diagnostic Systems, Inc.1995-03-09LCQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630915712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630915712040156309157124015630915712

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
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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