FDA.reportPublic FDA data

Dimension® Flex® reagent cartridge VALP

Primary DI
00842768005718
Brand
Dimension® Flex® reagent cartridge VALP
Company
Siemens Healthcare Diagnostics Inc.
Model
10444943
Catalog number
DF78
Device description
Valproic Acid 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
LEGENZYME IMMUNOASSAY, VALPROIC ACID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEGEnzyme Immunoassay, Valproic AcidClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982880000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982880000DIMENSION(R) VALPROIC (VALP) ACID METHODDade Behring, Inc.1998-08-25LEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768005718PrimaryGS10
00630414004303Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768005718008427680057188427680057180842768005718
00630414004303006304140043036304140043030630414004303

GMDN Terms#

Term, Definition table
TermDefinition
Valproic acid 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 valproic acid 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
4
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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