Precision DX
GUDID 00840050514283
AMERICAN SCREENING, L.L.C.
Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical| Primary Device ID | 00840050514283 |
| NIH Device Record Key | afe305ce-5bad-455f-b727-299ec2109831 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Precision DX |
| Version Model Number | PREDX-U-VACT |
| Company DUNS | 169065054 |
| Company Name | AMERICAN SCREENING, L.L.C. |
| 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 | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840050514283 [Primary] |
FDA Product Code
| QAW | Test, Tricyclic Antidepressants, Over The Counter |
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 | 2022-11-21 |
| Device Publish Date | 2022-11-11 |
On-Brand Devices [Precision DX]
Trademark Results [Precision DX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRECISION DX 87738447 not registered Live/Pending |
AMERICAN SCREENING, L.L.C. 2017-12-29 |
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