| Primary Device ID | 00816057020652 |
| NIH Device Record Key | 7fc3c5a1-f274-43fc-8006-f1a68f7ea4e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASI EB VCA IgM EIA Test |
| Version Model Number | NC-880096-AM |
| Catalog Number | NC-880096-AM |
| Company DUNS | 785966607 |
| Company Name | ARLINGTON SCIENTIFIC, 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 801-489-8911 |
| info@arlingtonscientific.com | |
| Phone | 801-489-8911 |
| info@arlingtonscientific.com | |
| Phone | 801-489-8911 |
| info@arlingtonscientific.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816057020652 [Primary] |
| LJN | Antibody Igm, If, Epstein-Barr Virus |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2016-07-08 |
| 00816057021666 - ASI Evolution | 2023-12-27 Automated RPR Analyzer. |
| 00816057021673 - ASI RPR Test for Syphilis for Use on the ASI Evolution | 2023-12-27 Syphilis Screening Test for Use on the ASI Evolution analyzer. 480 test kit |
| 00816057021680 - ASI RPR Test for Syphilis for Use on the ASI Evolution | 2023-12-27 Syphilis Screening Test for Use on the ASI Evolution Analyzer. 4800 test kit |
| 00816057021697 - ASI RPR Automated Control Set | 2023-12-27 RPR Control Set for use on the ASI Evolution Analyzer. 2.5 ml each of reactive, weak reactive and nonreactive controls. |
| 00816057021703 - ASI RPR Automated Control Set | 2023-12-27 RPR Control Set for use on the ASI Evolution Analyzer. 5.0 ml each of reactive, weak reactive and nonreactive controls |
| 00816057021710 - ASI Evolution RPR Titration Diluent | 2023-12-27 RPR Sample Diluent used on the ASI Evolution Analyzer for performing sample titrations. 25 ml |
| 00816057021796 - ASI RPR Card Test for Syphilis | 2023-12-27 Syphilis Screening Test with reactive and nonreactive controls. 100 test kit |
| 00816057021802 - ASI RPR Card Test for Syphilis | 2023-12-27 Syphilis Screening Test with reactive and nonreactive controls. 500 test kit |