Primary Device ID | 10810124273016 |
NIH Device Record Key | c8a3596e-5d7a-4524-b487-c3f408bca73f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SureStepTM Urine Test Drug Screen Strip, Buprenorphine (BUP10) |
Version Model Number | DBU-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 | 00810124273019 [Primary] |
GS1 | 10810124273016 [Unit of Use] |
DJG | Enzyme Immunoassay, Opiates |
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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