EVOLIS 89601
GUDID 03610520013328
EVOLIS
BIO-RAD
Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD| Primary Device ID | 03610520013328 |
| NIH Device Record Key | 630d0998-8a67-41c9-a014-100548a4473d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EVOLIS |
| Version Model Number | 89601 |
| Catalog Number | 89601 |
| Company DUNS | 269902602 |
| Company Name | BIO-RAD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com | |
| Phone | +1(800)224-6723 |
| TechSupport-Redmond@Bio-Rad.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03610520013328 [Primary] |
FDA Product Code
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
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 | 2023-02-13 |
| Device Publish Date | 2023-02-03 |
Devices Manufactured by BIO-RAD
| 03610520002933 - Select | 2023-08-09 MRSASelect |
| 03610520007860 - PLATELIA | 2023-08-09 PLATELIA Lyme IgM |
| 03610520007877 - PLATELIA | 2023-08-09 PLATELIA Lyme IgG |
| 03610522220519 - Platelia | 2023-07-11 Platelia SARS-CoV-2 Total Ab |
| 03610522220526 - Platelia | 2023-07-11 Platelia SARS-CoV-2 Total Ab |
| 03610520010785 - GEENIUS | 2023-02-13 Geenius Reader |
| 03610520013328 - EVOLIS | 2023-02-13EVOLIS |
| 03610520013328 - EVOLIS | 2023-02-13 EVOLIS |
| 03610520013571 - PR 4100 | 2023-02-13 PR 4100 |
Trademark Results [EVOLIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EVOLIS 79336892 not registered Live/Pending |
EVOLIS 2022-01-04 |
 EVOLIS 78170137 2825007 Live/Registered |
BIO-RAD LABORATORIES SAS 2002-10-02 |
 EVOLIS 76650474 3235604 Live/Registered |
EVOLIS 2005-11-16 |
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