Dimension Vista® Flex® reagent cartridge PTN

Primary DI
00842768015410
Brand
Dimension Vista® Flex® reagent cartridge PTN
Company
Siemens Healthcare Diagnostics Inc.
Model
10445125
Catalog number
K4064
Device description
Phenytoin Flex® reagent cartridge, 120 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
DIPENZYME IMMUNOASSAY, DIPHENYLHYDANTOIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIPEnzyme Immunoassay, DiphenylhydantoinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062024000DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGEDade Behring, Inc.2006-07-28LFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015410PrimaryGS10
00630414004969Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015410008427680154108427680154100842768015410
00630414004969006304140049696304140049690630414004969

GMDN Terms#

Term, Definition table
TermDefinition
Phenytoin 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 central nervous system drug phenytoin (e.g., Dilantin) 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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