| Primary Device ID | 08426950627692 |
| NIH Device Record Key | ae1091e1-cdac-4866-877d-088d28e5ef5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QUANTA Flash PR3 Reagents |
| Version Model Number | 701135 |
| 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 |
| TechSupport.na@werfen.com | |
| Phone | 1-800-545-9495 |
| TechSupport.na@werfen.com | |
| Phone | 1-800-545-9495 |
| TechSupport.na@werfen.com | |
| Phone | 1-800-545-9495 |
| TechSupport.na@werfen.com | |
| Phone | 1-800-545-9495 |
| TechSupport.na@werfen.com | |
| Phone | 1-800-545-9495 |
| TechSupport.na@werfen.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08426950627692 [Primary] |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-23 |
| Device Publish Date | 2024-12-13 |
| 08426950627692 - QUANTA Flash PR3 Reagents | 2024-12-231. QUANTA Flash PR3 Reagent Cartridge |
| 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 |
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| 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 |
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| 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 |