Primary Device ID | 10810124272996 |
NIH Device Record Key | aaafae10-4909-45f2-b4b8-e7492d3ab538 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 1000) |
Version Model Number | DAM-101-a-Sgl |
Company DUNS | 194854949 |
Company Name | ALERE SAN DIEGO, INC. |
Device Count | 50 |
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 | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810124272999 [Primary] |
GS1 | 10810124272996 [Unit of Use] |
DKZ | Enzyme Immunoassay, Amphetamine |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-25 |
Device Publish Date | 2023-12-15 |
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