Dimension Vista® Flex® reagent cartridge VANC

Primary DI
00842768015533
Brand
Dimension Vista® Flex® reagent cartridge VANC
Company
Siemens Healthcare Diagnostics Inc.
Model
10445128
Catalog number
K4086
Device description
Vancomycin Flex® reagent cartridge, 80 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
LEHRADIOIMMUNOASSAY, VANCOMYCIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEHRadioimmunoassay, VancomycinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061655000DIMENSION VISTA FLEX REAGENT CARTRIDGESDade Behring, Inc.2006-07-10LDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015533PrimaryGS10
00630414004990Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015533008427680155338427680155330842768015533
00630414004990006304140049906304140049900630414004990

GMDN Terms#

Term, Definition table
TermDefinition
Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug vancomycin in a clinical specimen, using a nephelometry/turbidimetry 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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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