Dimension Vista® Flex® reagent cartridge CA15-3

Primary DI
00842768028526
Brand
Dimension Vista® Flex® reagent cartridge CA15-3
Company
Siemens Healthcare Diagnostics Inc.
Model
10464344
Catalog number
K6456
Device description
LOCI CA 15-3 Flex® reagent cartridge, 160 Tests
Published
2016-09-24
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
MOISYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOISystem, Test, Immunological, Antigen, TumorImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100344000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100344000DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605Siemens Healthcare Diagnostics2011-04-18MOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768028526PrimaryGS10
00630414005591Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768028526008427680285268427680285260842768028526
00630414005591006304140055916304140055910630414005591

GMDN Terms#

Term, Definition table
TermDefinition
Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen using a chemiluminescent immunoassay 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
2
Lot or batch
true
Expiration date on label
true

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