| Primary Device ID | 08426950590583 |
| NIH Device Record Key | 84c11ae7-1bf4-4e95-8324-b8fe42a58c36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rubajet 500 TESTS |
| Version Model Number | 300024012 |
| Company DUNS | 460055742 |
| Company Name | BIOKIT, S.A. |
| 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 | 1-800-926-3353 |
| support@inovadx.com | |
| Phone | 1-800-926-3353 |
| support@inovadx.com | |
| Phone | 1-800-926-3353 |
| support@inovadx.com | |
| Phone | 1-800-926-3353 |
| support@inovadx.com | |
| Phone | 1-800-926-3353 |
| support@inovadx.com | |
| Phone | 1-800-926-3353 |
| support@inovadx.com | |
| Phone | 1-800-926-3353 |
| support@inovadx.com | |
| Phone | 1-800-926-3353 |
| support@inovadx.com | |
| Phone | 1-800-926-3353 |
| support@inovadx.com | |
| Phone | 1-800-926-3353 |
| support@inovadx.com | |
| Phone | 1-800-926-3353 |
| support@inovadx.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 |
| 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 | 08426950590583 [Primary] |
| LQN | Latex Agglutination Assay, Rubella |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-11-28 |
| Device Publish Date | 2016-09-23 |
| 08426950590569 - Rubagen 100 TESTS | 2022-11-28 1 x 1.7 ml LATEX REAGENT 1 x 1.0 ml HIGH POSITIVE CONTROL 1 x 1.0 ml LOW POSITIVE CONTROL 1 x 1.0 ml NEGATIVE CONTROL 1 x 35 ml |
| 08426950590576 - Rubajet 100 TESTS | 2022-11-28 1 x 1.7 ml LATEX REAGENT 1 x 1.5 ml HIGH POSITIVE CONTROL 1 x 1.5 ml LOW POSITIVE CONTROL 1 x 15 ml DILUENT BUFFER 13 disposable |
| 08426950590583 - Rubajet 500 TESTS | 2022-11-285 x 1.7 ml LATEX REAGENT 2 x 1.5 ml HIGH POSITIVE CONTROL 2 x 1.5 ml LOW POSITIVE CONTROL 2 x 15 ml DILUENT BUFFER 45 disposable slides |
| 08426950590583 - Rubajet 500 TESTS | 2022-11-28 5 x 1.7 ml LATEX REAGENT 2 x 1.5 ml HIGH POSITIVE CONTROL 2 x 1.5 ml LOW POSITIVE CONTROL 2 x 15 ml DILUENT BUFFER 45 disposable |
| 08426951056439 - biokitHSV-2 | 2022-10-18 20 Test Devices 20 x 0,7 ml Sample Diluent 20 x 0,5 ml Developing Reagent 20 x Empty Vials 1 20 x Pre-filter tips 20 x Capillary |
| 08426950639725 - BIO-FLASH | 2022-09-16 BIO-FLASH |
| 08426950589365 - Rheumajet CRP 100 TESTS | 2022-06-10 2 x 2.5 ml REAGENT 1 x 1.5 ml CONTROL + 1 x 1.5 ml CONTROL – 2 x 9 SLIDES |
| 08426950590460 - CRP Titer Control | 2022-06-10 2 x 1 ml titrated control |