ADVIA Centaur® CARB +Z

Primary DI
00630414527147
Brand
ADVIA Centaur® CARB +Z
Company
Siemens Healthcare Diagnostics Inc.
Model
10322035
Catalog number
5163003
Device description
Carbamazepine - CENTAUR - RGT - 250 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
KLTENZYME IMMUNOASSAY, CARBAMAZEPINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLTEnzyme Immunoassay, CarbamazepineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964765000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964765000CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAYChiron Diagnostics Corp.1997-02-14KLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414527147PrimaryGS10
00630414027630Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414527147006304145271476304145271470630414527147
00630414027630006304140276306304140276300630414027630

GMDN Terms#

Term, Definition table
TermDefinition
Carbamazepine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug carbamazepine in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend.
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
5
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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