FDA.reportPublic FDA data

Atellica IM CsA Calibrator

Primary DI
00630414598734
Brand
Atellica IM CsA Calibrator
Company
Siemens Healthcare Diagnostics Inc.
Model
10995549
Catalog number
10995549
Device description
Cyclosporine (CsA) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0mL
Published
2018-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DLJCalibrators, drug specific

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLJCalibrators, Drug SpecificClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071455000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071455000ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATORSiemens Medical Solutions Diagnostics2008-09-11MKW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414598734PrimaryGS10
00842768027383Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598734006304145987346304145987340630414598734
00842768027383008427680273838427680273830842768027383

GMDN Terms#

Term, Definition table
TermDefinition
Cyclosporin A/cyclosporine 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 immunosuppressant drug cyclosporin A or cyclosporine in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, 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
2
Lot or batch
true
Expiration date on label
true

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