FDA.reportPublic FDA data

Valproic Acid

Primary DI
04015630998913
Brand
Valproic Acid
Company
Roche Diagnostics GmbH
Model
4491041190
Catalog number
4491041190
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K060690000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060690000ONLINE VALPROIC ACIDRoche Diagnostics Corp.2006-08-08LEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630998913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630998913040156309989134015630998913

GMDN Terms#

Term, Definition table
TermDefinition
Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)A 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 an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04015630915989Free Valproic Acid ControlsRoche Diagnostics GmbHLEG2021-06-11
07613336121610Valproic AcidRoche Diagnostics GmbHLEG2020-03-05
07613336157794Valproic AcidRoche Diagnostics GmbHLEG2020-03-05
00380740154158AlinityABBOTT LABORATORIESLEG2018-12-12
00630414596013Atellica CH VPASiemens Healthcare Diagnostics Inc.LEG2017-12-27
00884883001305CEDIA Valproic Acid II AssayMicrogenics CorporationLEG2016-09-30
05055273206456VPARANDOX LABORATORIES LIMITEDLEG2016-09-24
00842768000942Syva® Emit® 2000 Valproic Acid AssaySiemens Healthcare Diagnostics Inc.LEG2016-09-24
00842768005718Dimension® Flex® reagent cartridge VALPSiemens Healthcare Diagnostics Inc.LEG2016-09-24
00842768015526Dimension Vista® Flex® reagent cartridge VALPSiemens Healthcare Diagnostics Inc.LEG2016-09-24
00842768023248Emit® 2000 Valproic AcidSiemens Healthcare Diagnostics Inc.LEG2016-09-24
00630414561950ADVIA® Chemistry VPA_2 Valproic Acid_2 ReagentsSiemens Healthcare Diagnostics Inc.LEG2016-09-24
00630414962290IMMULITE® 2000 Systems VAL Valproic AcidSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLEG2016-09-24
00630414964850IMMULITE®/IMMULITE® 1000 Systems VAL Valproic AcidSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLEG2016-09-24
04015630915958Valproic AcidRoche Diagnostics GmbHLEG2016-09-20
04015630997954Valproic Acid ONLINE TDM Valproic AcidRoche Diagnostics GmbHLEG2016-09-20
04015630999385Valproic AcidRoche Diagnostics GmbHLEG2016-09-20
10758750006748VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LEG2016-08-26
15099590222178SynchronBeckman Coulter, Inc.LEG2016-08-24
00380740000332ARCHITECTABBOTT LABORATORIESLEG2016-06-06
00380740001810ARCHITECTABBOTT LABORATORIESLEG2016-06-06
00380740001827ARCHITECTABBOTT LABORATORIESLEG2016-06-06