| Primary Device ID | 00816057020300 |
| NIH Device Record Key | 6217d940-016a-46ea-ace9-7f082879ffb2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASI Color Mono II Test |
| Version Model Number | NC-450100 |
| Catalog Number | NC-450100 |
| 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 | 00816057020300 [Primary] |
| KTN | System, Test, Infectious Mononucleosis |
| 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 |
| 00816057020324 | Detection of heterophil antibodies associated with infectious mononucleosis |
| 00816057020317 | Detection of heterophil antibodies associated with infectious mononucleosis, Export |
| 00816057020300 | Detection of heterophil antibodies associated with infectious mononucleosis |
| 00816057020294 | Detection of heterophil antibodies associated with infectious mononucleosis, Export |
| 00816057020287 | Detection of heterophil antibodies associated with infectious mononucleosis |
| 00816057020270 | Detection of heterophil antibodies associated with infectious mononucleosis, Export |
| 00816057020263 | Detection of heterophil antibodies associated with infectious mononucleosis |