| Primary Device ID | 08426950845249 |
| NIH Device Record Key | 7a388e60-7dd7-4165-9124-eb7f69fc977c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QUANTA Flash RF IgM Reagents |
| Version Model Number | 701340 |
| Company DUNS | 188354831 |
| Company Name | INOVA DIAGNOSTICS, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-545-9495 |
| support@inovadx.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08426950845249 [Primary] |
| DHR | System, Test, Rheumatoid Factor |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-30 |
| Device Publish Date | 2019-09-20 |
| 08426950627692 - QUANTA Flash PR3 Reagents | 2024-12-23 1. QUANTA Flash PR3 Reagent Cartridge |
| 08426950506355 - QUANTA Lite® Chromatin ELISA | 2024-11-07 1. 1x Chromatin ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL p |
| 00195126000871 - Aptiva® System Cleaning Solution Kit | 2024-03-26 The Aptiva System Cleaning Solution Kit is for use on the Aptiva Multi-Analyte Instrument to clean the instrument Optical Module |
| 00195126000741 - Aptiva® Instrument System Cuvettes | 2024-03-19 The Instrument System Cuvettes are intended for use on the Inova Diagnostics Aptiva® Multi-Analyte Instrument. Instrument Syste |
| 08426950865094 - QUANTA-Lyser® 3000 ELISA/IFA | 2024-03-19 QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a varie |
| 08426950865100 - QUANTA-Lyser ® 3000 ELISA/IFA+ Incubator | 2024-03-19 QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a varie |
| 08426950865131 - QUANTA-Lyser® 3000 /IFA | 2024-03-19 QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a varie |
| 08426951307227 - Aptiva® Multi-Analyte Instrument | 2024-03-19 Aptiva System is an automated particle-based multi-analyte analyzer for in vitro diagnostic testing of clincal specimens. The sy |