Fastep COVID-19 IgG/IgM Rapid Test Device

GUDID 06952804805029

ASSURE TECH. (HANGZHOU) CO., LTD.

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 06952804805029
• NIH Device Record Key: 8d67728e-0416-439a-9093-95b33c4329f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fastep COVID-19 IgG/IgM Rapid Test Device
• Version Model Number: 1.0
• Company DUNS: 530757741
• Company Name: ASSURE TECH. (HANGZHOU) CO., LTD.
• Device Count: 1
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06952804805029 [Primary]

FDA Product Code

• QKO: Reagent, Coronavirus Serological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-27
• Device Publish Date: 2021-01-19

Devices Manufactured by ASSURE TECH. (HANGZHOU) CO., LTD.

• 06952804805029 - Fastep COVID-19 IgG/IgM Rapid Test Device: 2021-01-27
• 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