Primary Device ID | 00840050513132 |
NIH Device Record Key | a5c926ae-8e30-4532-b771-2b1637a90f47 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Precision DX |
Version Model Number | PREDX-DUD1144N |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00840050513132 [Primary] |
NGG | Test, Methamphetamine, Over The Counter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-11-21 |
Device Publish Date | 2022-11-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRECISION DX 87738447 not registered Live/Pending |
AMERICAN SCREENING, L.L.C. 2017-12-29 |