Spartan RX CYP2C19 System 01003359

GUDID 00628055420040

Barcode Scanner supplied with the Spartan RX CYP2C19 System.

Spartan Bioscience Inc

Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Primary Device ID00628055420040
NIH Device Record Key1cd5485b-7bfe-43c5-a0f3-c9b800c564ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpartan RX CYP2C19 System
Version Model Number01003359
Catalog Number01003359
Company DUNS243605917
Company NameSpartan Bioscience Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100628055420040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NSUInstrumentation For Clinical Multiplex Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-26

On-Brand Devices [Spartan RX CYP2C19 System]

00628055420064This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (0100
00628055420101A box of 20 SNP CYP2C19 External Control Kits.
00628055420095A box of 10 CYP2C19 External Control Kits.
00628055420088A box of 20 CYP2C19 Sample Collection Kits.
00628055420071This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan RX Netbook (0100
00628055420057The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 System. It includes:
00628055420040Barcode Scanner supplied with the Spartan RX CYP2C19 System.
00628055420033Printer supplied with the Spartan RX CYP2C19 System
00628055420026Netbook supplied with the Spartan RX CYP2C19 System.
00628055420019Spartan RX Analyzer

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