FDA.reportPublic FDA data

COBAS FP Free Valproic Acid Calibrators

Primary DI
04015630915972
Brand
COBAS FP Free Valproic Acid Calibrators
Company
Roche Diagnostics GmbH
Model
20759031322
Catalog number
20759031322
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
DLJCALIBRATORS, DRUG SPECIFIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLJCalibrators, Drug SpecificClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954992000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954992000ROCHE COBAS INTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc.1996-01-25CIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630915972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630915972040156309159724015630915972

GMDN Terms#

Term, Definition table
TermDefinition
Valproic acid therapeutic drug monitoring IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug valproic acid in a clinical specimen.

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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