ADVIA Centaur® Systems CAL Calibrator Z

Primary DI
00630414527161
Brand
ADVIA Centaur® Systems CAL Calibrator Z
Company
Siemens Healthcare Diagnostics Inc.
Model
10322040
Catalog number
5165553
Device description
Carbamazepin (6PK) - CENTAUR - CAL - 6x2x5mL
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
DKBCALIBRATORS, DRUG MIXTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKBCalibrators, Drug MixtureClinical 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
00630414527161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414527161006304145271616304145271610630414527161

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-therapy 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 multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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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