| Primary Device ID | 00816057020928 |
| NIH Device Record Key | 1344c739-7bf5-48ff-8679-fa7d194c2e1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASI RPR Control Set |
| Version Model Number | NC-905002.5 |
| Catalog Number | NC-905002.5 |
| 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 | 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 |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816057020928 [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 |
| 00816057020973 | Detection of Syphilis |
| 00816057020966 | Detection of Syphilis, Custom |
| 00816057020959 | Detection of Syphilis |
| 00816057020942 | Detection of Syphilis, TDH |
| 00816057020935 | Detection of Syphilis, Custom |
| 00816057020928 | Detection of Syphilis |
| 00816057020911 | Detection of Syphilis |