Primary Device ID | 06970277512503 |
NIH Device Record Key | 655f5020-d659-44ef-b1df-818c3bf5a28e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cotinine (COT) Rapid Test Cassette |
Version Model Number | DCT-102 |
Catalog Number | DCT-102 |
Company DUNS | 543254717 |
Company Name | Hangzhou AllTest Biotech Co., Ltd. |
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 | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06970277512497 [Unit of Use] |
GS1 | 06970277512503 [Primary] |
MRS | Test System, Nicotine, Cotinine, Metabolites |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-10-09 |
Device Publish Date | 2018-09-08 |
16936983165416 - Multi-Drug 13 Drugs Rapid Test Cup | 2024-09-16 FDA Clia Waived, AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/FYL1 |
16936983165447 - Alltest Multi-Drug 12 Drugs Rapid Test Cup | 2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/OXY100/FYL1 |
16936983165454 - Alltest Multi-Drug 14 Drugs Rapid Test Cup | 2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1 |
16936983165461 - Multi-Drug 12 Drugs Rapid Test Cup | 2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/OXY100/FYL1 |
16936983165478 - Multi-Drug 14 Drugs Rapid Test Cup | 2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1 |
16936983165522 - Multi-Drug 14 Drugs Rapid Test Cup | 2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1)+(OXI/CRE/pH) |
06936983166256 - iScreen Urine Test DX Drug Screen Tox Cup | 2024-09-16 25T, FDA, CLIA WAIVED (AMP500/BAR300/BUP10/BZO300/COC150/FTY1/MDMA500/MET500/MOP300/MTD300/OXY100/PCP25/TCA1000/THC50)+(OXI/CRE/ |
06936983167116 - Shinetell Digital Pregnancy Test | 2024-09-16 1T, FDA OTC |