Primary Device ID | 10815845020383 |
NIH Device Record Key | 1963a24d-e352-4873-a418-54339cb869ac |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | DCT-102 |
Company DUNS | 194854949 |
Company Name | ALERE SAN DIEGO, INC. |
Device Count | 40 |
DM Exempt | false |
Pre-market Exempt | true |
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 | 00815845020386 [Unit of Use] |
GS1 | 10815845020383 [Primary] |
MRS | Test System, Nicotine, Cotinine, Metabolites |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2021-05-24 |
Device Publish Date | 2016-09-24 |
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