FDA.reportPublic FDA data

Spartan RX CYP2C19 System

Primary DI
00628055420033
Brand
Spartan RX CYP2C19 System
Company
Spartan Bioscience Inc
Model
01003438
Catalog number
01003438
Device description
Printer supplied with the Spartan RX CYP2C19 System
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NSUInstrumentation For Clinical Multiplex Test Systems
NTIDrug Metabolizing Enzyme Genotyping Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2
NTIDrug Metabolizing Enzyme Genotyping SystemsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123891000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123891000SPARTAN RX CYP2C19 TEST SYSTEMSpartan Bioscience, Inc.2013-08-12NTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628055420033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055420033006280554200336280554200330628055420033

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen prior to amplification, and generally operates with reduced technician involvement and automation of some, but not all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
243605917
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628055420088Spartan RX CYP2C19 System01004872-ABC01004872-ABC2016-09-26
00628055420095Spartan RX CYP2C19 System01004880-ABC (10)01004880-ABC (10)2016-09-26
00628055420101Spartan RX CYP2C19 System01004880-ABC (20)01004880-ABC (20)2016-09-26
00628055420019Spartan RX CYP2C19 System01004777010047772016-09-26
00628055420026Spartan RX CYP2C19 System01003214010032142016-09-26
00628055420040Spartan RX CYP2C19 System01003359010033592016-09-26
00628055420057Spartan RX CYP2C19 System01003374, 01003372, and 0100337301003374, 01003372, and 010033732016-09-26
00628055420064Spartan RX CYP2C19 System01004985010049852016-09-26
00628055420071Spartan RX CYP2C19 System01004985010049852016-09-26

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