FDA.reportPublic FDA data

Dimension® Flex® reagent cartridge CSAE

Primary DI
00842768005268
Brand
Dimension® Flex® reagent cartridge CSAE
Company
Siemens Healthcare Diagnostics Inc.
Model
10444934
Catalog number
DF108
Device description
Cyclosporine Extended Range Flex® reagent cartridge, 80 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
MKWCYCLOSPORINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKWCyclosporineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052017000CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108Dade Behring, Inc.2005-09-01MKW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768005268PrimaryGS10
00630414004198Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768005268008427680052688427680052680842768005268
00630414004198006304140041986304140041980630414004198

GMDN Terms#

Term, Definition table
TermDefinition
Cyclosporin A/cyclosporine 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 immunosuppressant drug cyclosporin A, or cyclosporine, 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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
4
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00869164000079Emit Cyclosporine SampleFUJIREBIO DIAGNOSTICS, INC.MKW2023-12-06
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00630414598727Atellica IM CsASiemens Healthcare Diagnostics Inc.MKW2018-02-06
00630414598741Atellica IM Multi-Diluent 12Siemens Healthcare Diagnostics Inc.MKW2018-02-06
00630414598765Atellica IM CsA PRE PretreatmentSiemens Healthcare Diagnostics Inc.MKW2018-02-06
00842768001451Syva® Emit® 2000 Cyclosporine Specific AssaySiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001468Syva® Emit® 2000 Cyclosporine Specific CalibratorsSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001475Syva® Emit® 2000 Cyclosporine Specific Negative CalibratorSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001482Syva® Emit® Cyclosporine Pretreatment ReagentSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768015144Dimension Vista® Flex® reagent cartridge CSASiemens Healthcare Diagnostics Inc.MKW2016-09-24
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00630414525549ADVIA Centaur® Multi-Diluent 12Siemens Healthcare Diagnostics Inc.MKW2016-09-24
04015630997459CSAII Cyclosporine IIRoche Diagnostics GmbHMKW2016-09-20
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