Fastep

GUDID 00810022630419

Azure Biotech, Inc.

SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 00810022630419
• NIH Device Record Key: 6b5b6585-081d-4a74-b1c7-8af82ceaf462
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fastep
• Version Model Number: COV-S35002H1
• Company DUNS: 051286548
• Company Name: Azure Biotech, Inc.
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00810022630419 [Primary]

FDA Product Code

• QKP: Coronavirus Antigen Detection Test System.

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-02
• Device Publish Date: 2023-09-22

On-Brand Devices [Fastep]

• 00810022630402: Fastep 10 Panel Urine Drug Test Cup (AMP, BUP, BZO, COC, MET, MDMA,MOP,MTD,OXY,THC) – 4 pack
• 00810022630396: Fastep 12 Panel Urine Drug Test Cup (AMP, BAR, BUP, BZO, COC, MET, MDMA, MOP,MTD, OXY, PCP, THC)
• 20810022630383: COV-S23010H25
• 00810022630440: COV-S35002H20
• 00810022630433: COV-S35002H4
• 00810022630426: COV-S35002H2
• 00810022630419: COV-S35002H1