Primary Device ID | 06952804801830 |
NIH Device Record Key | a6a3f9ce-e311-48ac-80f3-7be7bcbc6ebd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | hCG Pregnancy Serum/Urine Combo Test Strip(10/20) |
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 | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06952804801830 [Primary] |
JHI | Visual, Pregnancy Hcg, Prescription Use |
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 | 2017-07-25 |
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 |