Primary Device ID | 00628055420040 |
NIH Device Record Key | 1cd5485b-7bfe-43c5-a0f3-c9b800c564ec |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Spartan RX CYP2C19 System |
Version Model Number | 01003359 |
Catalog Number | 01003359 |
Company DUNS | 243605917 |
Company Name | Spartan Bioscience Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00628055420040 [Primary] |
NSU | Instrumentation For Clinical Multiplex Test Systems |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-26 |
00628055420064 | This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (0100 |
00628055420101 | A box of 20 SNP CYP2C19 External Control Kits. |
00628055420095 | A box of 10 CYP2C19 External Control Kits. |
00628055420088 | A box of 20 CYP2C19 Sample Collection Kits. |
00628055420071 | This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan RX Netbook (0100 |
00628055420057 | The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 System. It includes: |
00628055420040 | Barcode Scanner supplied with the Spartan RX CYP2C19 System. |
00628055420033 | Printer supplied with the Spartan RX CYP2C19 System |
00628055420026 | Netbook supplied with the Spartan RX CYP2C19 System. |
00628055420019 | Spartan RX Analyzer |