| Primary Device ID | 00816057021413 |
| NIH Device Record Key | 7f048582-d654-4c0f-bb8d-1f955b4f3a81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASI RPR Disposible Test Card |
| Version Model Number | NC-987015 |
| Catalog Number | NC-987015 |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | 801-489-8911 |
| info@arlingtonscientific.com | |
| Phone | 801-489-8911 |
| info@arlingtonscientific.com | |
| Phone | 801-489-8911 |
| info@arlingtonscientific.com |
| Area/Surface Area | 0.12 Square meter |
| Area/Surface Area | 0.12 Square meter |
| Area/Surface Area | 0.12 Square meter |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temp |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816057021413 [Primary] |
| GMP | Antisera, Control For Nontreponemal Tests |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-08 |
| 00816057021413 | Detection of Syphilis, 300 - 15 well |
| 00816057021383 | Detection of Syphilis, 1500 - 30 well |
| 00816057021314 | Detection of Syphilis, 25 - 10 well |
| 00816057021307 | Detection of Syphilis, 10-10well, generic |
| 00816057021291 | Detection of Syphilis, 10 - 10 well test cards |
| 00816057021284 | Detection of Syphilis, 50 - 10 well cards |