Identity
- Trade Name
- Fastep FDA UDI
- Generic Name
- SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- COV-S35002H4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810022630433 FDA UDI
- FDA Product Code
- QKP FDA UDI
- GMDN Term
- SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Fastep by Azure Biotech Inc — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical.
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- BD Veritor System for Rapid Detection of SARS-CoV-2 — BECTON DICKINSON AND COMPANY · Class II
- Fastep — AZURE BIOTECH INC · N
- Fastep — AZURE BIOTECH INC · N
- Fastep — AZURE BIOTECH INC · N
- Fastep — AZURE BIOTECH INC · N
- Fastep — AZURE BIOTECH INC · N
- Fastep — AZURE BIOTECH INC · N
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
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Manufacturer
- Manufacturer
- Azure Biotech Inc
Sources (1)
- FDA UDI 3dab9c3e-4845-47d3-bfdb-d659be43dc49 32 fields · synced May 30, 2026