ADVIA Centaur® Systems, ACS:180® Systems GENT Calibrator

Primary DI
00630414527284
Brand
ADVIA Centaur® Systems, ACS:180® Systems GENT Calibrator
Company
Siemens Healthcare Diagnostics Inc.
Model
10322159
Catalog number
5226110
Device description
Gentamicin - CENTAUR - CAL - 2x2x2mL
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
K953020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953020000ACS GENTAMICINCiba Corning Diagnostics Corp.1995-08-02LCD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414527284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414527284006304145272846304145272840630414527284

GMDN Terms#

Term, Definition table
TermDefinition
Gentamicin therapeutic drug monitoring IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug gentamicin in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00store upright
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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Primary DI, Brand, Company table
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