Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) FDA UDI
- Model / Reference
- COV-13C25 FDA UDI
- Description
- COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10722066005115 FDA UDI
- FDA Product Code
- QKO FDA UDI
- GMDN Term
- SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Rapid Response by BTNX Inc — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical.
- Fastep COVID-19 IgG/IgM Rapid Test Device — ASSURE TECH. (HANGZHOU) CO., LTD. · N
- Nano-CheckTM COVID-19 IgG/IgM Antibody Test — Nano-Ditech Corporation · N
- Lyher — Hangzhou Laihe Biotech Co., Ltd. · N
- ACON SARS-CoV-2 IgG/IgM Rapid Test — ACON Laboratories, Inc. · N
- CLIAWAIVED INC — CLIAWAIVED,INC.
- QuickProfile™ 2019-nCoV IgG/IgM Antibody Test — LumiQuick Diagnostics, Inc. · N
- Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit — Biohit Healthcare (Hefei) Co., Ltd. · N
- CLIAWAIVED INC — CLIAWAIVED,INC.
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
- BTNX Inc
Sources (1)
- FDA UDI d25bc97e-0a00-4b14-9c3c-3c4a13186d62 33 fields · synced May 31, 2026