FDA.reportPublic FDA data

COBAS Salicylate Calibrator

Primary DI
04015630915903
Brand
COBAS Salicylate Calibrator
Company
Roche Diagnostics GmbH
Model
20759198122
Catalog number
20759198122
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
04015630915903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630915903040156309159034015630915903

GMDN Terms#

Term, Definition table
TermDefinition
Salicylate IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of salicylate 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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