| Primary Device ID | 06952804801298 |
| NIH Device Record Key | 6891970f-f9b2-41fd-a6a0-243517869780 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Turn-Key Split Cup |
| Version Model Number | 1.0 |
| Company DUNS | 530757741 |
| Company Name | ASSURE TECH. (HANGZHOU) CO., LTD. |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06952804801298 [Primary] |
| DJG | Enzyme Immunoassay, Opiates |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-29 |
| 06952804805029 - Fastep COVID-19 IgG/IgM Rapid Test Device | 2021-01-27 |
| 06952804830212 - AssureTech Panel Dip Tests | 2018-10-08 AMP500, THC50, COC150, MET500, MOR300, BZO300, OXY100, BAR300, BUP10, MDMA500, PCP25, MTD300, EDDP300, TCA1000, PPX300 |
| 06952804830229 - AssureTech Quick Cup Tests | 2018-10-08 |
| 06952804802608 - AssureTech Panel Dip Tests | 2018-10-05 15 Strips, including MOR300 |
| 06952804802615 - AssureTech Quick Cup Tests | 2018-10-05 15 strips, including MOR300 |
| 06952804802622 - AssureTech Panel Dip Tests | 2018-10-05 15 strips, including MOR2000 |
| 06952804802639 - AssureTech Quick Cup Tests | 2018-10-05 15 strips, including MOR2000 |
| 06952804801083 - Panel Dip | 2018-07-06 |