FDA.reportPublic FDA data

Primidone

Primary DI
04015630915835
Brand
Primidone
Company
Roche Diagnostics GmbH
Model
20737887322
Catalog number
20737887322
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
LFTFLUORESCENT IMMUNOASSAY, PRIMIDONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFTFluorescent Immunoassay, PrimidoneClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K852318000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852318000COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORSRoche Diagnostic Systems, Inc.1985-06-25LFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630915835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630915835040156309158354015630915835

GMDN Terms#

Term, Definition table
TermDefinition
Primidone therapeutic drug monitoring IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug primidone in a clinical specimen, using a fluorescent immunoassay 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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