GeneSTAT
GUDID A91004001
Automated PCR analyzer
DXNA LLC
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated| Primary Device ID | A91004001 |
| NIH Device Record Key | c1dca0f5-5702-4b95-b4d5-ac634147dc47 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GeneSTAT |
| Version Model Number | 91004001 |
| Company DUNS | 789485377 |
| Company Name | DXNA LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com | |
| Phone | 4356280324 |
| techsupport@dxna.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | A91004001 [Primary] |
FDA Product Code
| QAA | Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-02 |
| Device Publish Date | 2018-05-31 |
Trademark Results [GeneSTAT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENESTAT 86191913 4714788 Live/Registered |
DXNA LLC 2014-02-12 |
 GENESTAT 77012156 not registered Dead/Abandoned |
Dx Nucleic Analytics, LLC 2006-10-03 |
 GENESTAT 75751385 not registered Dead/Abandoned |
BioDiscovery, Inc. 1999-06-25 |
 GENESTAT 74541978 not registered Dead/Abandoned |
PROMEGA CORPORATION 1994-06-24 |
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