FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge BHCG

Primary DI
00842768015540
Brand
Dimension Vista® Flex® reagent cartridge BHCG
Company
Siemens Healthcare Diagnostics Inc.
Model
10445107
Catalog number
K6430
Device description
Beta Human Chorionic Gonadotropin 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
DHASYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHASystem, Test, Human Chorionic GonadotropinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063754000DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632Dade Behring, Inc.2007-02-23DHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015540PrimaryGS10
00630414004808Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015540008427680155408427680155400842768015540
00630414004808006304140048086304140048080630414004808

GMDN Terms#

Term, Definition table
TermDefinition
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, 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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