Identity
- Trade Name
- Nano-CheckTM COVID-19 IgG/IgM Antibody Test FDA UDI
- Generic Name
- SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 virus using human blood/serum/plasma samples. FDA UDI
- Model / Reference
- MD8145 FDA UDI
- Description
- A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 virus using human blood/serum/plasma samples. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00895160002663 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Nano-CheckTM COVID-19 IgG/IgM Antibody Test by Nano-Ditech Corporation — 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
- Rapid Response — BTNX Inc · 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
- Nano-Ditech Corporation
Sources (1)
- FDA UDI 38899c11-c8db-46bd-993b-c54e7eb35130 34 fields · synced Jun 9, 2026