Precision DX
GUDID 00840050512289
AMERICAN SCREENING, L.L.C.
Multiple drugs of abuse IVD, kit, rapid ICT, clinical| Primary Device ID | 00840050512289 |
| NIH Device Record Key | 06fe98cd-01a9-4ec0-b04a-b0e725d21a4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Precision DX |
| Version Model Number | PREDX-DOA-234N |
| 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 | 00840050512289 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180349
FDA Product Code
| NFY | Test, Cocaine And Cocaine Metabolites, 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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