FDA.reportPublic FDA data

Spartan RX CYP2C19 System

Primary DI
00628055420101
Brand
Spartan RX CYP2C19 System
Company
Spartan Bioscience Inc
Model
01004880-ABC (20)
Catalog number
01004880-ABC (20)
Device description
A box of 20 SNP CYP2C19 External Control Kits.
Published
2016-09-26
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
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
00628055420101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055420101006280554201016280554201010628055420101

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid amplification mastermix kit IVDA collection of reagents and other associated materials intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)} in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
243605917
Device count
1
Kit
true
Lot or batch
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
00628055420019Spartan RX CYP2C19 System01004777010047772016-09-26
00628055420026Spartan RX CYP2C19 System01003214010032142016-09-26
00628055420033Spartan RX CYP2C19 System01003438010034382016-09-26
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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